FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
08/12/1992
RECALLS AND FIELD CORRECTIONS: August 12, 1992
CLASS I - FOODS
PRODUCT Jumex brand Fruit Nectars and Pineapple Apple Juice, in 12
fluid ounce dark blue cans with lead-soldered side seams and
white and yellow lettering directly on the cans:
(a) Apple Nectar; (b) Appricot Nectar; (c) Guava Nectar;
(d) Mango Nectar; (e) Papaya-Pineapple Nectar; (f) Peach Nectar;
(g) Pear Nectar; (h) Pineapple Juice; (i) Plum Nectar;
(j) Tamarind Nectar. Recall #F-411/420-2.
CODE All cans bearing the numbers 2084 and lower in the last four
numerical digits.
MANUFACTURER Empacadora de Frutas y Jugos, Mexico City, Mexico.
RECALLED BY Vilore Foods Company, Inc., Laredo, Texas, by letters of June
23 and 26, 1992 and July 13, 1992. Firm-initiated recall
ongoing. See also FDA press release P92-26, July 31, 1992.
DISTRIBUTION California, Florida, Illinois, Indiana, Texas.
QUANTITY Unknown.
REASON Products contaminated with high levels of lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
UPDATE Recall #F-442-2, Tropical Delite Fruit Punch Soda, manufactured
by the Cotton Club Bottling Company, which appeared in the July
29, 1992 Enforcement, has been cancelled. Sample results
indicated the punch did not contain FD&C Yellow #5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Coca-Cola Classic, Carbonated Cola-Flavored Soft Drink, in 10
fluid ounce glass non-returnable bottles, in 16 fluid ounce
plastic bottles, and in 2 liter plastic non-returnable
bottles. Recall #F-462-2.
CODE 2160TH (10 oz); 2155TH (16 oz); 2161TH, 2162TH and 2170TH (2
liters).
MANUFACTURER Coca-Cola Bottling Works of Tullahoma, Inc., Tullahoma,
Tennessee.
RECALLED BY Manufacturer, by visit June 22, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Tennessee.
QUANTITY Unknown quantity was distributed, however, firm management
estimated that only about 30 percent of the quantities
distributed would have remained on the market at the time of
recall initiation.
REASON Product is contaminated with gear lubricant.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
PRODUCT Dynaspray 888 Skin Eye Spray, in 2 fluid ounce plastic spray
bottles and in 16 fluid ounce plastic refill bottles.
Recall #D-449-2.
CODE None.
MANUFACTURER Undetermined.
RECALLED BY Janta International Company (J.I.C.), San Francisco,
California, by letter mailed on December 5, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION California, Taiwan.
QUANTITY 864 2-fluid ounce and 66 16-fluid ounce bottles were
distributed between October 22, 1990 and December 4, 1991. In
addition, an undetermined number of bottles were given to
friends and fellow church members.
REASON Non-sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Floxin (ofloxacin) Tablets, 400 mg, in 50 tablet bottles, a Rx
antibiotic. Recall #D-445-2.
CODE Lot numbers: M2897, M2898, M2900 EXP 11/92 (for all lots).
MANUFACTURER McNeil Pharmaceutical, Spring House, Pennsylvania.
RECALLED BY Ortho Pharmaceutical Corporation, Raritan, New Jersey, by
letter June 12, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 14,961 bottles of lot FM2897, 14,944 bottles of lot FM2898, and
14,904 bottles of lot FM2900 were distributed.
REASON Product does not meet dissolution specifications.
-2-
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Fioricet, an oral tablet containing acetaminophen, 325 mg;
caffeine, 40 mg and butalbital, 50 mg, a Rx oral dose, packaged
in blisters of 4, 5 blisters/box used as an analgesic.
Recall #D-446-2.
CODE Lot #725P2882 EXP 1/95.
MANUFACTURER Sandoz Pharmaceuticals, East Hanover, New Jersey.
RECALLED BY Manufacturer, by letter June 19, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 32,984 x 20 tablets were distributed.
REASON Product does not meet dissolution specifications.
PRODUCT Tussionex Pennkinetic (hydrocodone polistirex and
chlorpheniramine polistirex), Extended-Release Suspension, in
pint bottles and 900 ml bottles, an Rx product for relief of
cough and upper respiratory symptoms associated with allergy or
a cold. Recall #D-447-2.
CODE Lot numbers: Pint bottles - R0007 EXP 8/93, R0008, R0009,
R0010, R0011, R0012 (all with 10/93 EXP date); 900 ml bottles -
R0116 EXP 11/93.
MANUFACTURER American Crystal Sugar, Moorehead, Minnesota.
RECALLED BY Fisons Corporation, Rochester, New York, by letter July 21,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 38,000 pint bottles and 250 900-ml bottles were distributed;
firm estimates 80 percent remains on the market.
REASON Presence of small metallic flakes.
PRODUCT N.E.E. 1/35 Norethindrone and Ethinyl Estradiol Tablets USP, a
Rx oral contraceptive on a blister card. Recall #D-448-2.
CODE Lot #93002A2 EXP 3/95.
MANUFACTURER Watson Laboratories, Inc., Corona, California.
RECALLED BY Manufacturer, by letters of April 30, 1992 and May 18, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,884 cartons were distributed.
REASON Some shelf cartons labeled as containing "21 Day" packages
contain "28 Day" packages.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-367/368-2.
CODE Unit #90-03964.
MANUFACTURER The Reading Hospital and Medical Center, West Reading,
Pennsylvania.
-3-
RECALLED BY Manufacturer, by telephone June 16 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Maryland.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were collected
from a donor who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-365/366-2.
CODE Unit numbers: (a) L33826; (b) L33826, L36214, L38255.
MANUFACTURER Lancaster General Hospital, Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letter June 19, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania and Maryland.
QUANTITY (a) 1 unit; (b) 3 units.
REASON Blood products, which either tested initially reactive for the
antibody to human immunodeficiency virus type 1 (anti-HIV-1),
or tested negative for anti-HIV-1 but were collected from a
donor who previously tested reactive for anti-HIV-1, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells. Recall #B-369-2.
CODE Unit #LQ 02499.
MANUFACTURER The Reading Hospital and Medical Center, West Reading,
Pennsylvania.
RECALLED BY Consignee notified firm on or about June 21, 1991.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Red Blood Cells labeled with the incorrect expiration date were
distributed.
PRODUCT Recovered Plasma. Recall #B-371-2.
CODE Unit #91-1171.
MANUFACTURER Davis Memorial Hospital, Elkins, West Virginia.
RECALLED BY Manufacturer, by letters of June 24 and 30, 1992.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 1 unit.
REASON Blood product which tested initially reactive for the hepatitis
B surface antigen (HBsAg), was distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis.
Recall #B-373/374-2.
CODE Unit numbers: (a) 11R77455; (b) 11P58116.
-4-
MANUFACTURER American Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, (a) by telephone and follow-up letter dated
February 14, 1992; (b) by telephone and follow-up letter dated
December 6, 1991. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit of each component.
REASON Blood products untested for the antibody to the hepatitis C
virus (anti-HCV) or syphilis, were distributed.
PRODUCT Antihemophilic Factor (Human). Recall #B-377-2.
CODE Lot #29359094AA.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY Manufacturer, by telephone April 26, 1990. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY 50 vials were distributed. Firm estimates none remains on the
market.
REASON Antihemophilic Factor (Human), stored at room temperature for
an unacceptable time period, was distributed.
PRODUCT Whole Blood. Recall #B-388-2.
CODE Unit #42J65995.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY Consignee notified firm by telephone March 1, 1991. Recall
complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
PRODUCT (a) Synchrony II Dual Chamber Pacemaker; (b) Solus Single
Chamber Pacemaker. Recall #Z-854/855-2.
CODE Serial numbers: (a) 2022T, 2023M, 2023M/S;
(b) 2002T, 2023M, 2023M/S.
MANUFACTURER Siemens Pacesetter Systems, Inc., Sylmar, California.
RECALLED BY Manufacturer. On May 29, 1992 Pacesetter instructed their
representatives to visit all of the customers and recover any
unused affected units. On June 5, 1992 Pacesetter notified
patient's physicians by letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 2,353 units were distributed. Siemens reports 2
pacemakers remain to be accounted for.
REASON Due to the new version of computer software, Rev. B, a pulse
rate anomaly may develop in when they are programmed to "sensor
on" or to "sensor passive".
PRODUCT Lifepak 300 Automatic Advisory Defibrillators, Part #804900-.
Recall #Z-867-2.
-5-
CODE All dash and serial numbers shipped after November 4, 1991.
MANUFACTURER Physio-Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by letter hand delivered by service
representatives at time of equipment malfunction beginning
April 6, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 463 units were distributed.
REASON An electronic component with a particular date code may fail
during use, causing the LIFEPAK 300 to be inoperative.
PRODUCT Lifepak 300 Semi-Automatic Advisory Defibrillator.
Recall #Z-868-2.
CODE Serial numbers 337 and ending with 3460 which are not
continuous.
MANUFACTURER Physio-Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by letter June 22, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,765 units were distributed.
REASON There is a potential for hybrid circuit to fail because of its
susceptibility to the effects of temperature and humidity. The
failure of this component may cause the instruments to display
continuous motion detected alarms which render the device
inoperative in the automatic mode.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Dornier S2000/18 Electrodes, used in Extracorporeal Shock Wave
Lithotripter Models HM3, HM4, MFL5000, and MPL9000.
Recall #Z-869-2.
CODE Lot numbers M04.2 and M05.2.
MANUFACTURER Dornier Medizintechnik GMBH, Germering, Germany.
RECALLED BY Dornier Medical Systems, Kennesaw, Georgia, by letter May 15,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,124 electrodes were distributed.
REASON The white plastic insulator is cracking, especially near the
electrode tip. The damaged electrode may cause the lithotripsy
procedure not to work.
PRODUCT Corometrics 116 Fetal Monitor, intended to monitor heart rate
and uterine activity, primarily during labor. Recall #Z-870-2.
CODE All models distributed from 1/1/92 to 5/15/92.
MANUFACTURER Corometrics Medical Systems, Inc., Wallingford, Connecticut.
RECALLED BY Manufacturer, by letters of May 29, 1992 and June 10, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 638 units were distributed.
-6-
REASON Due to a design change in the ultrasound printed circuit board,
the ultrasound performance may be degraded under certain
circumstances. In those patients which present technical
challenges (obesity, etc.), artifacts and/or difficulty in
obtaining fetal heart rate tracings, audible signals and visual
symbol may result.
PRODUCT McGaw Intelligent (infusion) Pumps, intended for use with McGaw
Intelligent Pump I.V. Sets to regulate the flow of I.V. fluids
when positive pressure is required:
(a) Catalog #521; (b) Catalog #521C (Microrate);
(c) Catalog #125 (521 Plus); (d) Catalog #125C (Microrate Plus);
(e) Catalog #522. Recall #Z-896/900-2.
CODE All serial numbers manufactured prior to 4/1/91. Serial number
range: (a) P1000 through P7200; (b) C1000 through C1406;
(c) H1000 through H3700; (d) K1001 through K1865;
(e) D1001 through D11100.
MANUFACTURER McGaw, Inc., Carrollton, Texas.
RECALLED BY McGaw, Inc., Irvine, California, by letter March 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18,508 units were distributed between August 1985 and March
1991.
REASON The lower inner door hinge pin may work its way out. If a pump
which is missing the lower inner door hinge pin is used, it may
result in volumetric error (under-infusion) in excess of the
+/- 2% specification.
PRODUCT Bio-Medicus Extracorporeal Circulation Cannulas labeled as (a)
Pediatric Arterial Cannulas, 19 cm, 12 French, product
#96820-012;
(b) BioMedicus Cannula with Introducer, Venous, 10 French, 19
cm, with Carmeda BioActive Surface, product #CB96835-010.
Recall #Z-901/902-2.
CODE Lot numbers: (a) 010792; (b) K1R54.
MANUFACTURER Medtronic Bio-Medicus, Inc., Eden Prairie, Minnesota.
RECALLED BY Manufacturer, by telephone beginning June 12, 1992, followed by
letter June 25, 1992. Firm-initiated recall complete.
DISTRIBUTION Texas, South Carolina, Michigan, Washington, D.C., California,
Minnesota, New York, Wisconsin, Canada.
QUANTITY (a) 28 units; (b) 16 units were distributed.
REASON The Pediatric Arterial Cannulas were actually venous cannulas
and the Biomedicus Cannula with Introducer, Venous was actually
an arterial cannula.
PRODUCT Machine Counter Torque Devices for (a) CeraOne Abutments,
stainless steel, Model DIA 263 (single tooth);
(b) EsthetiCone Abutments, stainless steel, Model DIA 271
(conical system). Devices are used with torque controller and
machine screwdriver to prevent transferring of torque to the
-7-
fixture during tightening of the abutment screw during single
tooth replacement or fixed bridge restorations.
Recall #Z-903/904-2.
CODE All units shipped between 1/25/91 and 3/11/91.
MANUFACTURER Saxbolaget, Arjang, Sweden.
RECALLED BY Nobelpharma USA, Inc., Chicago, Illinois (importer), by
telephone June 3, 1992 followed by letter dated June 2, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 39 units; (b) 35 units were distributed.
REASON The incorrect solder was used between the hexagon casing and
the handle which may cause the device to break at the solder
joint.
PRODUCT ECG Lead Sets and Electrodes used in specific Vista and Vista
HPQ Models 0.5T, 1.0T, and 1.5T Magnetic Resonance Imaging
Systems. Recall #Z-947-2.
CODE HFO-HF1, HF3, HF5-HF10, HF12, HF14-HF15, HF17-HF18, HF20-HF23,
HF25-HF26, HR28-HR30, HF32-HF35, HF38, HF44, HF50, HF54-HF55,
HF57-HF59, HF62, HF65, HF70, HF72, HF74-HF75, HF77-HF78,
HF80-HF81, HF92, HF94, QH106-QH113, QH115-QH122, QH124,
QH126-QH129, QH131-QH137, QH139-QH140, QH142-QH143,
QH148-QH150, QH156, QF106-QF114, QF116-QH118, QF120-QF124,
QF126, QF128-QF129, QF132-QF133, QF135-QF141, QF146, QA106,
QA110-QA111.
MANUFACTURER Picker International, Solon, Ohio.
RECALLED BY Picker International, Inc., Highland Heights, Ohio, by letter
January 20, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, United Kingdom, Japan, Saudi Arabia, Iran,
Switzerland.
QUANTITY 125 units were distributed.
REASON The leads and electrodes can become hot during MR imaging due
to radio frequency heating, resulting in the patient being
burned.
PRODUCT MVP X-Ray Controls with Console Models 46-903825 (G1, G5, G10);
Model 45432761; Model 45433285. Recall #Z-949/951-2.
CODE All serial numbers.
MANUFACTURER General Electric Medical Systems, Milwaukee, Wisconsin.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
July 2, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,350 units were distributed.
REASON MVP controls which utilize tubes with 0.3 mm focal spot sizes
may fail to comply with control and indication of technique
factors - accuracy, and entrance exposure rate limits -
equipment with automatic exposure rate control.
PRODUCT MAXIMA-10 Flash Autoclave (tabletop), 17" W x 2" D x 19.5" H,
electrically powered. Recall #Z-952-2.
CODE Serial numbers: 190001, 190002, 190004, 190005, 190006,
190009, 190010, 190011, 190012, 190013, 191001, 191002, 191003,
-8-
191005, 191006, 101007, 191008, 191009, 1910010, 191011,
191012, 191014, 191015, 191020, 101021, 191022, 191023, 191025,
191026, 191027, 191031, 191032.
MANUFACTURER Stirn Industries, Dayton, New Jersey.
RECALLED BY Manufacturer, by telephone April 23, 1992 and by letter April
24, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, France.
QUANTITY 32 units were distributed.
REASON The device was distributed into commerce without an approved
510(k).
PRODUCT Tanning Beds, Suntamed - Uvastar Models:
(a) Model 400; (b) Model 800; (c) Model 2000;
(d) Model 4000; (e) Model 6000. Recall #Z-953/957-2.
CODE Serial numbers: Undetermined.
MANUFACTURER Uvatec, Inc./Solitec GmbH, Studio City, California.
RECALLED BY Manufacturer. FDA approved the firm corrective action plan
July 7, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 347 units were distributed.
REASON Noncompliance with the performance standard for sunlamp
products in that the beds lacked adequate labeling as well as
required information.
PRODUCT Advantx X-Ray Systems and the LFX and MPPU Versions:
(a) Model 46-289657; (b) Model 46-275979; (c) Model 46-289804;
(d) Model 46-26537G1; (e) Model 46-275910G1;
(f) Model 46-275910G2; (g) Model 4539769. Recall #Z-960/966-2.
CODE All serial numbers.
MANUFACTURER General Electric Medical Systems, Milwaukee, Wisconsin.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
July 2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,300 units were distributed.
REASON Noncompliance with control and indication of technique factors
- accuracy, and entrance exposure rate limits for equipment
with automatic exposure rate control as required by the
performance standard for diagnostic x-ray systems and their
major components.
PRODUCT AME Carbon One Cervical/Thoracic Orthosis, a single-patient use
device designed for immobilization of the cervical spine.
Recall #Z-967-2.
CODE Order numbers: 90341, 90416, 91052, 91277, 91410, 91602,
92127, 92158, 92365, 92426, 92555, 92622, 92721, 92727, 92744,
93083, 93084, 93272, 93622, 93877, 93878, 94064, 94076, 94086,
94460, 94750, 94862, 94879, 94898, 95150, 95163, 95236.
MANUFACTURER American Medical Electronics, Inc., Richardson, Texas.
RECALLED BY Manufacturer, by letter July 7, 1992. Firm-initiated recall
ongoing.
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DISTRIBUTION Nationwide, Japan, Taiwan.
QUANTITY 90 units.
REASON Bolts in the anterior assembly, posterior assembly and lateral
pads may break.
PRODUCT Sales brochures, operating manuals, maintenance manuals and
other labeling for Arjo-Century's Hydrosound Patient Bathing
Systems. Hydrosound is a sonic device incorporated into
various bathing systems which emits sound waves creating
bubbles in the water to aid in cleansing the skin.
Recall #Z-968-2.
CODE All sale brochures, labeling and manuals accompanying Models
000, 001, 001A Hydrosound Systems.
MANUFACTURER Century Manufacturing Company, Inc., Aurora, Nebraska (system);
Swen Sonic Corporation, Davenport, Iowa (Hydrosound).
RECALLED BY Arjo-Century, Inc., Morton Grove, Illinois, by general sales
bulletin June 17, 1992 and by letter July 2, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 136 units were distributed.
REASON The labeling, manuals and marketing labeling brochures misbrand
the bathing system for use in dermal wound healing, claims that
have not been approved in a PMA.
PRODUCT RMI Dual Drainage Venous Return Cannula, indicated for venous
cannulation so that extracorporeal circulation of venous blood
to a heart-lung machine may be achieved. Recall #Z-969-2.
CODE Catalog #TR-3240-L, lot #71911.
MANUFACTURER Research Medical, Inc., Midvale, Utah.
RECALLED BY Manufacturer, by telephone between June 11 and 17, 1992,
followed by letter July 7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Virginia, Texas, New York, Alabama, California, Massachusetts,
Michigan, Illinois, Montana, Wisconsin, Idaho, Missouri, Ohio,
Kentucky, Pennsylvania, international.
QUANTITY 1,017 units were distributed; firm estimates 140 units remain
in domestic distribution.
REASON Some of the peel-pouches containing the device were not sealed
during the packaging process; product packaged in the
non-sealed pouch is considered to be non-sterile.
PRODUCT Oxygen Pressure Regulator w/Constant Flow Controller, used to
provide regulated pressure and flow to a demand valve,
aspirator or automatic ventilator. Recall #Z-970-2.
CODE Model #270-060, lot #107747.
MANUFACTURER Life Support Products, Inc., Irvine, California.
RECALLED BY Manufacturer, by telephone on or about May 5, 1992, followed by
letter May 15, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California, Virginia, Pennsylvania, Arizona.
QUANTITY 18 units were distributed.
REASON The labeled calibrations on the flow knob may not match the
actual flow knob.
-10-
PRODUCT Siemens Sonoline Diagnostic Ultrasound Imaging Systems,
designed for cardiac applications and for general hospital
imaging: (a) Model CF; (b) Model CF+. Recall #Z-971/972-2.
CODE Serial numbers: (a) 00101 to 00181;
(b) CPN *****, (* = a number), for U.S. models, and CPP *****,
for foreign models.
MANUFACTURER Siemens-Quantum Inc (current name),
Siemens Ultrasound, Inc. (previous name), San Ramon, California.
New location: Issaquah, Washington.
RECALLED BY Manufacturer, by issuing two notifications, UT-182 and UT-183
on November 14, 1990 and October 31, 1990 respectively to field
service personnel instructing removal of defective software and
installation of new software. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 385 systems were distributed.
REASON Software defect may result in miscalculated heart rates and
stroke volume; and overheating of the Panasonic VCR Model 7300
resulting in interference with the operation of the device,
either temporarily or permanently.
PRODUCT Siemens Sonoline Diagnostic Ultrasound Imaging Systems,
intended as restricted device for hospital use only:
(a) Model SL-1; (b) Model SL-2; (c) Model SI-200;
(d) Model SI-250. Recall #Z-973/976-2.
CODE Serial numbers: (a) NA *****, (* = a number);
(b) KA *****; (c) SA *****; (d) NA *****.
MANUFACTURER Siemens-Quantum, Inc., Issaquah, Washington; Matsushita
Communications Industrial Company, Ltd., Toyko, Japan (SL-1 &
SL-2 Model). Design specifier - Siemens AG, Erlangen, Germany.
RECALLED BY Siemens-Quantum, Inc., San Ramon, California by field service
notification UT 196 dated April 8, 1991. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Central-South America, Canada, East Asia, Pacific
Island.
QUANTITY Approximately 2,500 systems were distributed.
REASON There is a potential for misdiagnosis of fetal weight when
using the Hadlock equation incorporated into the software.
PRODUCT Siemens Sonoline CF Systems, a diagnostic ultrasound imaging
system bearing Siemens name, model identification number or
letter, designed for cardiac applications and for general
hospital imaging. Recall #Z-977-2.
CODE Serial numbers: 00101 to 00181, numbered sequentially.
MANUFACTURER Siemens-Quantum Inc (current name),
Siemens Ultrasound, Inc. (previous name), San Ramon, California.
New location: Issaquah, Washington.
RECALLED BY Manufacturer, by issuing "UT-174", dated February 20, 1990.
Firm-initiated field correction ongoing.
-11-
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 385 units were distributed.
REASON There is a potential for probe overheating and transmit power
failures, as well as ECG trace displaying a portion of the
previous scan due to software errors.
PRODUCT Siemens Sonoline Diagnostic Ultrasound Imaging Systems,
designed for cardiac applications and for general hospital
imaging: (a) model CF+; (b) Model SI-1200.
Recall #Z-978/979-2.
CODE Serial numbers: (a) CPN ***** (* = a number), for U.S. models
and CPP ***** for foreign models; (b) CSN *****, for U.S.
Models, and CSP ***** for foreign models.
MANUFACTURER Siemens-Quantum Inc (current name),
Siemens Ultrasound, Inc. (previous name), San Ramon, California.
New location: Issaquah, Washington.
RECALLED BY Manufacturer, by issuing notification "UT-205", July 25, 1991
with corrective software Rev. 6.11, and issuance of the user
letter dated August 2, 1991. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 385 units were distributed.
REASON The 7.5 MHz probe can exceed the specified maximum temperature.
PRODUCT COBE CentrySystem 3 Dialysis Control Units, perform the
necessary control functions for hemodialysis therapy:
1. Catalog No. 333100-001;
2. Catalog No. 333100-112;
3. Catalog No. 333100-012;
4. Catalog No. 333100-102;
5. Catalog No. 333100-017;
6. Catalog No. 333100-014;
7. Catalog No. 333100-011;
8. Catalog No. 333100-118;
9. Catalog No. 333100-101;
10. Catalog No. 333100-117;
11. Catalog No. 333100-111;
12. Catalog No. 333100-013. Recall #Z-980/991-2
CODE Serial numbers 3C20000 through 3C20992.
MANUFACTURER CGH Medical, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by letter May 20, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 992 units were distributed.
REASON Hardware conversions are being made to the devices to improve
the overall reliability of the equipment, enhance its
serviceability, promote the overall safety margin associated
with the equipment's weight removal function, and to bring the
units up to the current upgrade configuration.
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PRODUCT COBE CentrySystem 2 Dialysis Control Units, performs the
necessary control functions for hemodialysis therapy; and COBE
Ultrafiltration Control Modules, provides volumetric control of
ultrafiltration:
1. CentrySystem 2 Dialysis Unit Catalog No. 018763-101;
2. CentrySystem 2 Dialysis Unit Catalog No. 018773-101;
3. CentrySystem 2 Dialysis Unit Catalog No. 018773-112;
4. CentrySystem 2 Dialysis Unit Catalog No. 018773-111;
5. CentrySystem 2 Dialysis Unit Catalog No. 018763-111;
6. CentrySystem 2 Dialysis Unit Catalog No. 018773-111;
7. CentrySystem 2 Dialysis Unit Catalog No. 018773-121;
8. Ultrafiltration Control Module Catalog No. 018492-001;
9. Ultrafiltration Control Module Catalog No. 018492-011.
Recall #Z-992/1000-2.
CODE Serial numbers: (1-7) 2C51092 through 2C1184, 2C51231 through
2C1420; (8 & 9) UF00679 through UF00681, UF00687 through
UF00751.
MANUFACTURER CGH Medical, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by letter May 20, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION (1-7) Nationwide, Italy, France, Chile, Hong Kong, Portugal,
Tunisia, Sweden, Mexico, Taiwan, Korea, Japan;
(8 & 9) Mississippi, Florida, California, Washington state,
Ohio, Kentucky, Canada, Australia, France, England, Taiwan,
Tunisa.
QUANTITY (1-7) 143 units; (8 & 9) 52 units were distributed.
REASON Hardware conversions are being made to the devices to improve
the overall reliability of the equipment, enhance its
serviceability, promote the overall safety margin associated
with the equipment's weight removal function, and to bring the
units up to the current upgrade configuration.
PRODUCT Vinyl Examination Gloves used by health professionals during
routine medical examination, in boxes of 100. Recall #Z-1001-2.
CODE Catalog #482005, lot #2B203Q.
MANUFACTURER Becton Dickinson Medical Gloves Division, Los Gatos, California.
RECALLED BY Becton Dickinson and Company, Becton Division Medical Gloves
Division, Franklin Lakes, New Jersey, by telephone March 18 and
19, 1992 and by letter March 18, 1992. Firm-initiated recall
complete.
DISTRIBUTION California, Maryland, Massachusetts, New Hampshire, New Jersey,
New York, Pennsylvania, Washington state.
QUANTITY 87,000 gloves were distributed; firm estimates 10 percent
remains on the market.
REASON Product failed the FDA leak test.
PRODUCT (a) SBS Series Laser Light Show Projectors;
(b) SBT Series Laser Light Show Projectors.
Recall #Z-1002/1003-2.
CODE Serial numbers: (a) SBS090A; (b) SBT-091A, SBT-092A.
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MANUFACTURER Los Angeles Laser Light, also known as Laser Light, Reseda,
California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
July 14, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION California and Japan.
QUANTITY 3 units were distributed.
REASON Noncompliance with the performance standards for laser products
in that the protective housing which is designed to be opened
for user maintenance and allows access to Class IV levels of
laser radiation failed to incorporate safety interlocks, and
the warning logotypes failed to provide the maximum output of
the product and the laser medium or emitted wavelengths.
PRODUCT Datascope Intra-Aortic Balloon Pump Systems, for use as a
patient aid for pre-, intra-, or post-operative open-heart
surgery; patients with unstable angina; patients with left main
artery occlusion or poor left ventricular function:
(a) Datascope System 90 Intra-Aortic Balloon Pump;
(b) Datascope System 90 Transport, also known as 90T,
Intra-Aortic Balloon Pump. Recall #Z-1153/1154-2.
CODE Part No. Serial number range
(a) 0998-00-0058-01 2000 to 4075-K1 (not inclusive)
0988-00-0058-02
0998-00-0058-04
(b) 0998-00-0060-01 1008 to 2325-K1 (not inclusive)
0998-00-0060-02
0998-00-0060-04.
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by service representative visit beginning April
10, 1992 per Technical Bulletin #397. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Canada, Holland.
QUANTITY 2,467 units were distributed;
REASON There has been an increase in the replacement rate of the 20
PSI pressure relief valve (Part #0103-07-0001) due to premature
aging of the valve, which can lead to reduced pneumatic
performance (the catheter is not augmented).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Chronicure, a natural protein hydrolysate powder specifically
designed for the management of chronic wounds and dermal
ulcers, packaged in 30 gram bottles. Recall #Z-958-2.
CODE Lot #2S96P.
MANUFACTURER ABS Life Sciences, Inc., West Chester, Pennsylvania.
RECALLED BY Manufacturer, by letter January 17, 1992, followed by telephone
February 3, 1992, and by letter February 4, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 135 bottles were distributed; firm estimates none remains on
the market.
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REASON Device was clumpy instead of fluffy and free-flowing as
labeled; some units were shipped without insert sheets; some
units' inner tamper-indicating seals did not fit properly and
therefore are prone to failure; label corners were coming off
bottles; and units were shipped without adequate quality
control/quality assurance release.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT (a) Atrial Bipolar Pacing Leads, Model 699OU;
(b) Atrial Bipolar Pacing Leads, Model 4502.
Safety Alert #M-087/088-2.
CODE All lots.
MANUFACTURER Medtronic, Inc., Cardiac Pacing Business, Minneapolis,
Minnesota.
ALERTED BY Manufacturer, by letter July 17, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 6,692 leads were distributed; (b) 1,183 leads were
distributed.
REASON Leads may fail more frequently than the firm had previously
thought due to insulation failure. The actuarial survival of
the Model 6990U is 93.6+/-5.7% at 5 years and 86.1 +/-9.0% at
90 months. The Model 4502 is 90.8 +/-7.4% at 5 years and 88.6
+/- at 90 months.
SEIZURES
PRODUCT Oxygen USP (92-641-310).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the products' processing, packaging, and
holding do not conform to and are not operated and administered
in conformity with current good manufacturing practice
requirements.
FIRM Crest Medical, Inc., El Centro, California.
FILED June 25, 1992; U.S. District Court for the Southern
District of California; Civil #92-965H(LSP), FDC #66364.
SEIZED July 22, 1992 - goods valued at approximately $10,000.
PRODUCT Frozen fish fillets, fish nuggets, and fish fingers
(92-610-597/600).
CHARGE Adulterated - The products consist in part of decomposed fish.
Misbranded - The products are offered for sale under the name
of pollock or cod, but are actually a mixture of fish species.
FIRM University of Illinois Housing Food Store, Champaign, Illinois.
FILED June 30, 1992 - U.S. District Court for the Central
District of Illinois; Civil #C 92-2196, FDC #66444.
SEIZED July 16, 1992 - goods valued at approximately $10,000.
PRODUCT Canned fava beans (92-610-596).
CHARGE Adulterated - The products either consist in part of a filthy
substance because they contain insects and insect damaged
beans; or they have been prepared and packed under insanitary
conditions whereby they may have become contaminated with filth.
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FIRM The Fremont Company, Milford, Illinois.
FILED June 30, 1992 - U.S. District Court for the Central
District of Illinois; Civil #C 92-2195, FDC #66443.
SEIZED July 15, 1992 - goods valued at approximately $2,500.
PRODUCT Chunk Light Tuna in Water (92-638-033).
CHARGE Adulterated - The product consists in part of decomposed
tuna fish; and the product is pet food which has been
relabeled as human food, thus concealing its inferiority.
Misbranded - The product is offered for sale under the name
of another food.
FIRM Rhode Island Community Food Bank, West Warwick, Rhode Island.
FILED July 31, 1992 - U.S. District Court for the District
of Rhode Island; Civil #CA 92-0413, FDC #66477.
SEIZED August 3, 1992 - goods valued at approximately $10,880.
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END OF ENFORCEMENT REPORT FOR AUGUST 12, 1992. BLANK PAGES MAY
FOLLOW.
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