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
08/17/1994
Recalls and Field Corrections: Foods -- Class II -- 08/17/1994
August 17, 1994 94-33
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Sutliff Creme Candy Wafers, Green, in 1 pound and 2 pound
boxes. Recall #F-762-4.
CODE None.
MANUFACTURER Sutliff Candy Company, Seattle, Washington.
RECALLED BY Manufacturer, by telephone June 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
QUANTITY Firm estimates none remains on the market.
REASON Product contained undeclared FD&C Yellow No. 5.
_______________
PRODUCT Monaka Cookies: (a) Monaka Cookies (Ssook Monaka) Mugwort,
in 6 ounce plastic trays; (b) Monaka Cookies - (Hopak
Monaka) Pumpkin, in 6 ounce plastic trays.
Recall #F-763/764-4.
CODE None
MANUFACTURER Sang Won Trading Company, Ltd., Seoul, Korea.
RECALLED BY Jin Han International, Inc., Brooklyn, New York, by letters
delivered early July 1994. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Connecticut.
QUANTITY 60 cartons (24 packages per carton) were distributed.
REASON Product contains undeclared FD&C Yellow No. 5 and undeclared
Blue No. 1.
_______________
PRODUCT Hilsha Fish, frozen whole fish, approximately 3 pounds each.
Recall #F-767-4.
CODE All fish purchased during January 1994.
MANUFACTURER Meghna Sea Foods Ltd., Chittagong, Bangladesh (packer).
RECALLED BY ABF Food & Trading Corporation, Brooklyn, New York
(importer), by letter July 21, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY 100 cases were distributed; firm estimates none remains on
the market.
REASON Product was contaminated with Salmonella.
_______________
PRODUCT Various fountain syrups: (a) Apple Magic, Caramel Flavored;
(b) Apple Magic, Green Color; (c) Cotton Candy Magic, Lemon
Flavored; (d) Cotton Candy Magic, Lime Flavored; (e) Top
Hat/big Chief Fountain Syrup, Imitation Pineapple Syrup; (f)
Top Hat/Big Chief Fountain Syrup, Imitation Banana Syrup;
(g) Top Hat/Big Chief Fountain Syrup, Lemon Flavored Syrup;
(h) Top Hat/Big Chief Fountain Syrup, Lemon Slush; (i) Top
Hat/Big Chief Fountain Syrup, Lime Slush.
Recall #F-769/777-4.
CODE Date codes between 6/93 to present.
MANUFACTURER Victor Products Corporation, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about June 15, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 35 cases; (b) 17 cases; (c) 40 cases; (d) 25 cases (e)
35 cases; (f) 73 cases; (g) 23 cases; (h) 60 cases; (i) 60
cases; (j) 48 cases; (k) 12 cases; (l) 85 cases were
distributed.
REASON Products contain undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Hawaiian Punch, Fruit Punch, Fruit Juicy Red flavored, in 12
fluid ounce cans. Recall #F-778-4.
CODE C174J.
MANUFACTURER Pepsi Cola General Bottlers, Inc., Kansas City, Missouri.
RECALLED BY Manufacturer, by letter April 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION Kansas, Missouri, Iowa.
QUANTITY Approximately 78,000 cans were distributed.
REASON Product contains mold and yeast.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III
====================
_______________
PRODUCT Cy-Nan Medicated Organic Shampoo, in 8 fluid ounce plastic
bottles. Recall #F-768-4.
-2- CODE None.
MANUFACTURER Cy-Nan Products, Ltd., Elmhurst, New York.
RECALLED BY Manufacturer, by letter July 11, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 276 bottles were distributed; firm estimated 30 percent of
the product remained on market at time of recall.
REASON Product contains delisted FD&C Red No. 19.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Maxair Autohaler Pirbuterol Acetate Inhalation Aerosol, 0.2
mg per actuation, 80-dose professional sample, 2.8 g,
indicated for prevention and reversal of bronchospasm.
Recall #D-343-4.
CODE 931224, 931265, 940019, 940405.
MANUFACTURER 3M Pharmaceuticals, Inc., Northridge, California.
RECALLED BY 3M Pharmaceuticals, St. Paul, Minnesota, by letter July 21,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 302,998 80-dose units were distributed.
REASON Some units do not deliver consistent doses.
_______________
PRODUCT Liquid Medical Oxygen, filled into 40 liter patient
cryogenic vessels. Recall #D-344-4.
CODE All codes, all lots, and all fill dates.
MANUFACTURER J & J Home Health Care and Surgical, Inc., Bayshore, New
York.
RECALLED BY Manufacturer, by visit July 22, 1994. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 2 vessels were distributed.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Cephradine Capsules, USP, 500 mg, Rx oral antibiotic.
Recall #D-345-4.
CODE Lot numbers: 1334015, 1360112, 2036118, 2013070, 2015105,
2002019, 2024084, 1329048, 2006080, 2016113, 1338086,
1341125.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey
(responsible firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letter July 17, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION California, Nevada, Oregon, Pennsylvania, Mississippi,
Oklahoma, Florida, Illinois, Tennessee, U.S. Virgin Islands.
-3- QUANTITY 51 bottles of 9, 205 bottles of 15, 15 bottles of 30, 40
bottles of 4, 600 bottles of 20, 60 bottles of 40 and 40
bottles of 14 capsules were distributed; firm estimated that
10 percent of the product remained on the market at time of
recall.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
======================
_______________
PRODUCT Immune Globulin Intravenous (Human), distributed in amounts
of 0.5g, 2.5g, 5.0g, and 10.0g, under the labels Gammagard
and Polygam. Recall #B-422-4.
CODE All lots manufactured since February 1993.
MANUFACTURER Hyland Division, Baxter Healthcare Corp., Los Angeles,
California; Hyland Division, N.V. Baxter S.A., Lessines,
Belgium.
RECALLED BY Baxter Healthcare Corporation, Glendale, California, by
letter February 23, 1994. Firm-initiated recall ongoing.
See also FDA talk paper T94-14, February 25, 1994.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Immune Globulin Intravenous (IGIV) (Human), associated with
transmission of hepatitis C, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-382-4.
CODE Unit #3302362.
MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY Manufacturer, by telephone October 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Alaska.
QUANTITY 1 unit.
REASON Blood product which was collected from a donor at increased
risk for infectious diseases was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-394-4.
CODE Unit #1313056.
MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by fax March 15, 1994. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1) and Western Blot positive was distributed.
-4- _______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Pooled;
(d) Cryoprecipitated AHF, Pooled; (e) Fresh Frozen Plasma;
(f) Recovered Plasma. Recall #B-406/411-4.
CODE (a) Units F65228, G91946, GP17487, H87702, LG22910, LM15497
LM41159, P60731, S45261, X61484;
(b) Units GP11676, GP17487, LG22910, LM41159, S45261;
(c) Pool numbers FF10120 (contained recalled Platelet unit
P75982), FF32224 (contained recalled Platelet unit LM15497),
LP23923 (contained recalled Platelet unit P60731);
(d) Pool numbers FF08352 (contained recalled
Cryoprecipitated AHF unit H87702), FF23756 (contained
recalled cryoprecipitated AFH unit X61484), and GZ08149
(contained recalled Cryoprecipitated AHF unit F65228;
(e) Units GP11676, GP17487, LM15497, LM41159, P60731,
P75982;
(f) F65228, G91946, H87702, LG22910, S45261, X61484.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by letter dated April 8 or 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION California, North Carolina, Wisconsin.
QUANTITY (a) 10 units; (b) 5 units; (c) 3 units; (d) 3 units; (e) 6
units; (f) 6 units.
REASON Blood products that tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1) but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1 were distributed.
_______________
PRODUCT Source Plasma. Recall #B-412-4.
CODE Unit numbers: PK42201, PK42370, XK16892, XK16940, XK17055,
XK17079, XK17187, XK44444, XK44912.
MANUFACTURER Community Bio-Resources, Inc., Louisville, Kentucky.
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama, by
letter January 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 9 units.
REASON Blood products, that tested negative for hepatitis B surface
antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-413-4.
CODE Units XK06980, XK07033, XK07102, XK07162, XK07197, XK07294,
XK07321, XK07465, XK09208, XK15904, XK16000, XK16025,
XK16103, XK16185, XK16293, XK16376, XK16441.
MANUFACTURER Mid-South Blood Service, Inc., and Community Bio-Resources,
Inc., Louisville, Kentucky.
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama, by
letter April 26, 1994. Firm-initiated recall complete.
DISTRIBUTION Austria.
-5- QUANTITY 17 units.
REASON Blood products that tested negative for hepatitis B surface
antigen (HBsAg) but were collected from a donor who
previously tested repeatedly reactive for HBsAg were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-414-4.
CODE Unit numbers: PK04649, PK04722, PK04834, PK04881, PK04998,
PK05333, PK05464, PK05747, PK05811, PK06009, PK06235,
PK06340, PK06514, PK06626, PK06778, PK06875, PK08686,
PK08800, PK09049, PK09298, PK09520, PK09633, PK09800,
PK09894, PK10055, PK10115, PK10244, PK10465, PK10537,
PK10699, PK10790, PK14071, PK24723, PK25020, PK42792,
PK42875, PK43049, PK43522, PK43565, PK43696, PK43858,
PK43921, PK44121, PK44225, PK44362, PK44441, XK01836,
XK01873, XK01967, XK01999, XK02082, XK02134, XK02217,
XK02272, XK02347, XK02395, XK02486, XK02535, XK02625,
XK02724, XK02805, XK02873, XK03024, XK03074, XK03181,
XK03250, XK03334, XK03378, XK03493, XK03545, XK03649,
XK03699, XK03774, XK03857, XK03951, XK04039, XK04107,
XK04592, XK04639, XK04693, XK23828, XK23911, XK24043,
XK24128, XK24337, XK24429, XK24532, XK24704, XK24888,
XK24943, XK25095, XK25122, XK25186, XK25290, XK25405,
XK25617, XK25793, XK25844, XK26147, XK26282, XK26352,
XK26620, XK26947, XK27034, XK27254, XK27311, XK27494,
XK27775, XK27930, XK28268, XK28575, XK28768, XK29113,
XK29193, XK29569, XK29787, XK30153, XK30403, XK30798,
XK31398, XK31703, XK32110, XK32342, XK32762, XK33071,
XK33458, XK33956, XK34284, XK34622, XK34826, XK35344,
XK35580, XK36082, XK36411, XK37006, XK37315, XK37854,
XK38209, XK38971, XK39519, XK39761, XK40304, XK40623,
XK41138, XK41425, XK41886, XK42141, XK42612, XK42897,
XK43392, XK43704, XK44238, XK44581, XK45083, XK45461,
XK45994, XK46298, XK46773, XK47080, XK47575, XK48345,
XK49128, XK49303, XK49904, XK51458, XK52713, XK53354,
XK53680, XK54365, XK55029, XK55181, XK55812, XK56358,
XK56675, XK57446, XK57775, XK58350, XK58629, XK59209,
XK59502, XK59697, XK60078, XK60388, XK61027, XK61362,
XK62038, XK62880, XK63194, XK65927, XK67600, XK68361,
XK68837, XK70628, XK71088, XK72491, XK73695, XK74618,
XK75730, XK76824, XK77308, XK79999, XK80321, XK81013,
XK81637, XK82198, XK83406, XK84588, XK85050, XK86572,
XK87764, XK88824, XK89653, and XK92252
MANUFACTURER Mid South Blood Service, Inc., and Community Bio-Resources,
Inc., Louisville, Kentucky.
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama, by
letter May 10, 1994. Firm-initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 213 units.
REASON Blood products, that tested negative for hepatitis B surface
antigen (Hbsag), but were collected from donors who
previously tested repeatedly reactive for Hbsag, were
distributed. -6- _______________
PRODUCT Source Plasma. Recall #B-417-4.
CODE Unit numbers: PS41090, PS41272, PS41725, PS42195, PS42429,
PS42806, PS43012, PS46020, PS46208.
MANUFACTURER Community Bio-Resources, Inc., Orlando, Florida.
RECALLED BY Community Bio-Resources, Inc., Columbus, Georgia, by letter
January 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, Austria.
QUANTITY 9 units.
REASON Units of source plasma, which tested negative for hepatitis
B surface antigen (HBsAg), but were collected from a donor
who had previously tested repeatedly reactive for HBsAg,
were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-420-4.
CODE Unit numbers: 02F09958, 02F09966, 02G57402, 02G57412,
02G57507, 02G57824, 02G58024, 02G58083, 02G57913, 02H74908,
02H75094, 02J67466, 02J67485, 02LL32270.
MANUFACTURER The American National Red Cross, Wichita, Kansas.
RECALLED BY Manufacturer, by telephone February 17, 1992 and by letter
on April 14, 1992. Firm-initiated recall complete.
DISTRIBUTION Kansas.
QUANTITY 14 units.
REASON Blood products stored at unacceptable temperatures were
distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-421-4.
CODE Unit 1250350.
MANUFACTURER Michigan Community Blood Center, Saginaw, Michigan.
RECALLED BY Manufacturer, by telephone April 19, 1993, followed by
letter dated April 22, 1993. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON A unit of Platelets, Pheresis was distributed labeled with
an incorrect expiration date.
_______________
PRODUCT Red Blood Cells. Recall #B-425-4.
CODE Unit #7791017.
MANUFACTURER First Medical Group (ACC) Blood Bank, Langley, AFB,
Virginia.
RECALLED BY Manufacturer, by electronic mail June 17, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product collected from an ineligible donor in that the
donor answered affirmatively to a screening question
indicative of symptoms of infection with the human
immunodeficiency virus type 1 (HIV-1) was distributed.
-7- _______________
PRODUCT Recovered Plasma. Recall #B-426-4.
CODE Unit numbers: 0053749, 0053756, 0053759, 0054267, 0054270,
0054272.
MANUFACTURER Baystate Medical Center, Springfield, Massachusetts.
RECALLED BY Manufacturer, by letter July 1, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 6 units.
REASON Blood products incorrectly tested for the antibodies to the
human immunodeficiency virus type 1 and 2 (anti-HIV-1/2)
were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-427-4.
CODE Unit #2260281.
MANUFACTURER Kenner Army Hospital Blood Bank, Fort Lee, Virginia.
RECALLED BY Manufacturer, by letter June 3, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey, Saudi Arabia.
QUANTITY 1 unit.
REASON Blood product collected from a donor whose health history
screening was inadequately performed, was distributed.
RECALLS AND FIELD CORRECTIONS -- BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Recovered Plasma. Recall #B-399-4.
CODE Unit #1A07615.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas.
RECALLED BY Manufacturer, by telephone September 14, 1993. Firm-
initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product collected from an autologous donor in which
all suitability requirements for allogeneic use were not
determined was distributed.
_______________
PRODUCT Allergenic Extracts, in 10 ml and 30 ml vials: (a)
Asparagus; (b) Avocado, 10 ml only; (c) Cabbage; (d)
Cantaloupe; (e) Cucumber; (f) Grapefruit.
Recall #B-400/405-4.
CODE Lot numbers: (a) A10030194; (b) A11021494; (c) C12031494;
(d) C13032294; (e) C360022394; (f) G10020294.
MANUFACTURER Antigen Laboratories, Inc., Liberty, Missouri.
RECALLED BY Manufacturer, by telephone May 24-26, 1994, followed by
letter May 25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Colorado, Georgia, Illinois, Iowa, New York, Ohio, Oklahoma,
Pennsylvania, Texas.
QUANTITY 12 10-ml vials and 3 30-ml vials were distributed.
-8- REASON Allergenic extracts manufactured with the incorrect sodium
chloride concentration were distributed.
_______________
PRODUCT Platelets. Recall #B-416-4.
CODE Unit #11048-1180.
MANUFACTURER Blood Systems, Inc., doing business as United Blood Service,
El Paso, Texas.
RECALLED BY Manufacturer, by telephone November 9, 1993 and by letter
November 11, 1993. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product shipped at an unacceptable temperature was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-418/419-4.
CODE Unit numbers: (a) 22-09456; (b) 22-09456, 22-09454.
MANUFACTURER Itasca Medical Center, Grand Rapids, Minnesota.
RECALLED BY Manufacturer, by telephone on or about March 3 and 4, 1994,
followed by letter March 4, 1994. Firm-initiated recall
complete.
DISTRIBUTION Minnesota, Massachusetts.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products, which tested reactive for syphilis by the
Rapid Plasma Reagin (RPR) test were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Critikon brand Sterile Disposa-Cuf Neonatal Blood Pressure
Monitoring Cuff, for use with Dinamap neonatal vital signs
monitors only. Recall #Z-741-4.
CODE Product #8312, lot #M1087.
MANUFACTURER Johnson Medical, Inc., El Paso, Texas.
RECALLED BY Critikon, Inc., Tampa, Florida, by telephone February 28,
1994, followed by letter March 3, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Ohio, North Carolina, Pennsylvania, Kansas, New
York, Washington state, Michigan, Louisiana, California,
Florida.
QUANTITY 55 boxes were distributed.
REASON Product labeled as sterile but did not go through any
sterilization procedure.
_______________
PRODUCT Sterile Mucus Specimen Traps with a suction catheter, used
for oral suction in newborns:
(a) Product #SMT80655; (b) Product #SMT80855;
(c) Product #SMT81055; (d) Product #SMT81255;
(e) Product #SMT81455; (f) Product #SMT90655;
-9- (g) Product #SMT90855; (h) Product #SMT91055;
(i) Product #SMT91255; (j) SMT91455. Recall #Z-1204/1213-4.
CODE All lots shipped prior to June 10, 1994, (lot #S06104 or
less).
MANUFACTURER Tri-State Hospital Supply, Corporation, Inc., Howell,
Michigan.
RECALLED BY Manufacturer, by letter June 16, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 45,400 units remained on market at time
of recall.
REASON The end of the catheter was cut off on some units during
packaging. This can cause occlusion in the catheter and
cause pain upon use.
_______________
PRODUCT Unprotected patient cables and lead wires in CardioMapp
Mapping Systems, personal computer based devices for
amplifying, displaying and capturing cardiac signals, used
by cardiologists and electrophysiologists in the correction
of various arrhythmias. The systems are also designed to
detect Wolfe-Parkinson-White Syndrome and ventricular
tachycardia. The CardioMapp Mapping Systems are available
in the following three configurations:
CardioMapp 63, a 63 amplifier model; CardioMapp 127, a 127
amplifier model; CardioMapp 255, a 255 amplifier model.
Recall #Z-1214/1215-4.
CODES Serial numbers:
CardioMapp 63 - CM017J1810X, CM038J3011X, CM053E1313
CardioMapp 127 - CM005D2010Y, CM006E0410Y, CM007E2110Y,
CM009F0710Y, CM010F2210Y, CM013G1710Y, CM014H1710Y,
CM015H2410Y, CM011I0510Y, CM018J1810Y, CM019K2110Y,
CM020K2110Y, CM02211810Y, CM023A0711Y, CM025A2111Y,
CM026A3111Y, CM028C2011Y, CM030E0311Y, CM032H2111Y,
CM036H2811Y, CM043C1712, CM044C2412, CM047L2912,
CM048B1013, CM050C1713, CM052F2513, CM057A1014
CardioMapp 255 - CM004D0910Z, CM008E2110Z, CM016J1810Z,
CM024A2111Z, CM027A3111Z, CM029C2711Z, CM031E2511Z,
CM034H1211Z, CM033I0111Z, CM035I0611Z, CM037J2211Z,
CM040L0311Z, CM041C1712Z, CM045I2912, CM046J2212,
CM049C1713, CM056J2113, CM058A1014.
MANUFACTURER Prucka Engineering, Inc., Houston, Texas.
RECALLED BY Manufacturer, by letter June 9, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 48 units distributed between February 1990 and February
1994.
REASON Labels fail to provide adequate directions for use, and the
cables and lead wires pose an unwarranted risk of injury to
patients because they are not labeled to contraindicate use
with apnea monitors.
-10- _______________
PRODUCT Unprotected lead wires in Neuro Technology brand Peripheral
Nerve Stimulators as follows:
(a) DigiStim 2 Plus labeled as dual-purpose to efficiently
monitor muscle relaxants and precisely locate nerves in
regional anesthesia procedures;
(b) DigiStim 3 Plus labeled as a full-featured peripheral
nerve stimulator in a convenient, hand-held unit;
(c) MicroStim Plus labeled as a complete muscle relaxant
monitor that fits in the palm of the hand;
(d) DigiStim II labeled as a dual-purpose peripheral nerve
stimulator that efficiently monitors muscle relaxants and
precisely locates nerves in regional anesthesia procedures;
(e) DigiStim III labeled as a full-featured peripheral
nerve stimulator in a convenient, hand-held unit;
(f) MicroStim labeled as a complete muscle relaxant monitor
that fits in the palm of the hand;
(g) StimPen labeled as a pocket-sized, fully functional
muscle relaxant monitor for use when other monitors are not
readily available;
(h) NeuroStim II labeled as a dual-purpose peripheral nerve
stimulator that efficiently monitors muscle relaxants and
precisely locates nerves in regional anesthesia procedures.
Recall #Z-1216-4.
CODE Serial Numbers (a) IA2041056-IA2041061,
IA2061062-IA2061073, IA2071074, IA2081077-IA2081080,
IA2091081-IA2091084, IA2101185-IA2101188,
IA2111189-IA2111194, IA2121198-IA2121200,
IA3011201-IA3011204, IA3021205-IA3021235,
IA3041238-IA3041239, IA3101240-IA3101257,
IA3111258-IA3111266, IA3121272-IA3121294;
(b) HA2011144-HA2011145, HA2061135-HA2061147,
HA2071148-HA2071155, HA2081156-HA2081182,
HA2091183-HA2091196, HA2101188-HA2101191,
HA2111192-HA2111202, HA2121203-HA2121220,
HA3021221-HA3021275, HA3071276-HA3071289,
HA3101290-HA3101316, HA3111320-HA3111344,
HA3121345-HA3121346, HB3041001-HB3041004,
HC2081128-HC2081132, HC3021001, HC3081002-HC3081004,
HE2061071-HE2061090, HE2091091-HE2091110,
HE2121113-HE2121132, HE3021133-HE3021152,
HE3041153-HE3041172, HE3101173-HE3101182,
HE3111183-HE3111197, HF2051126-HF2051275,
HF2091276-HF2091445, HF2101446-HF2101485,
HF2121486-HF2121555, HF3021001-HF3021030,
HF3031031-HF3031060, HF3051061-HF3051090,
HF3061091-HF3061150, HF3091161-HF3091190,
HF3101191-HF3101220, HF3111221-HF3111290,
HF4011302-HF4011331;
(c) GA1121179-GA1121209, GA2031210-GA2031305, GA2111306,
GA2111307, GA2121308-GA2121320, GA3011334-GA3011357,
-11- GA3021358-GA3021382, GA3031391-GA3031407,
GA3061408-GA3061505, GA3101508-GA3101623,
GA3111624-GA3111681, GB1059620-GB1059624,
GB2054801-GB2055100, GB2061001-GB2061002,
GB2061501-GB2061732, GB2071733-GB2071807,
GB2081808-GB2081813, GB2091814-GB2091816, GB2101818,
GB2102001-GB2103650, GB2113651-GB2114400,
GB2124151-GB2124153, GB3014154-GB3014162,
GB3031001-GB3031300, GB3041301-GB3041650,
GB3059952-GB3059965, GB3069966, GB3071651-GB3072100,
GB3079975, GB3072101-GB3073225, GB3109992-GB3109993,
GB3129994-GB3129999, GC2021301-GC2021500,
GC2031501-GC2032000, GC2049607, GC2042001-GC2043500,
GC2049608-GC2049610, GC2053501-GC2054800,
GC2059611-GC2059619, GC2064801-GC2065500, GC2089620,
GC3079968-GC3049974, GC3089968-GC3089991,
GF2051401-GF2051600, GF2061601-GF2061750,
GF2091751-GF2091950, GF2101951-GF2102050,
GF2122051-GF2122150, GF3022151-GF3022250,
GF3032251-GF3032350, GF3052351-GF3052470,
GF3072471-GF3072510, GF3092515-GF3092574,
GF3112635-GF3112674, GF4012681-GF4012720;
(d) AA2041438-AA2041465, AA2051457-AA2051459,
AA2061466-AA2061491, AA2071492-AA2071498,
AA2081501-AA2081521, AA2091522-AA2091568,
AA2101568-AA2101586, AA2111587-AA2111588,
AA2121589-AA2121602, AA3011603, AA3021604-AA3021646,
AA3031647-AA3031662, AA3051663-AA3051694,
AA3081692-AA3081700, AA3111701-AA3111721,
AA3121722-AA3121745, AB2061004-AB2061007, AB3021008,
AB3061000, AB3101001, AC2041001, AC2061002,
AD2061013-AD2061033;
(e) CA2042622-CA2042648, CA2052648-CA2052684,
CA2062685-CA2062731, CA2072732-CA2072760,
CA2082763-CA2082834, CA2092835-CA2092865,
CA2102865-CA2102934, CA2112935-CA2112945,
CA2122946-CA2122971, CA3012974-CA3013004,
CA3023005-CA3023034, CA3033035-CA3033133,
CA3043134-CA3043196, CA3053197-CA3053243,
CA3063244-CA3063302, CA3073303, CA3103304-CA3103361,
CA3123362-CA3123450, CB2071154, CB2081155-CB2081156,
CB2111157-CB2111161, CB2121162, CB3011163,
CB3021164-CB3031166, CB3031167, CB3041168,
CB3071169-CB3071170, CB3091169, CB3101170-CB3101173;
(f) EA1102164, EA2012246-EA2012250, EA2042261-EA2042287,
EA2052288-EA2052293, EA2062293-EA2062389,
EA2072390-EA2072410, EA2082411-EA2082452,
EA2102453-EA2102538, EA2112539-EA2112569,
EA2122570-EA2122602, EA3012603-EA3012624,
EA3022625-EA3022675, EA3032676-EA3032804,
EA3042805-EA3042874, EA3052875-EA3052899,
EA3082900-EA3082980, EA3102981-EA3103070,
-12- EA3113071-EA3113117, EA3123118-EA3123199,
EB2041005-EB2041012, EB2051013-EB2051017,
EB2061018-EB2061024, EA2071025-EB2071027,
EB2081028-EB2081029, EB2091030-EB2091032,
EB2101033-EB2101046, EB2121048-EB2121049,
EB3021001-EB3021012, EB3041013, EB3071014,
EB3081014-EB3081023, EB3111024-EB3111027,
EF2042512-EF2042661, EF2052662-EF2052761,
EF2072762-EF2072811, EF2082812-EF2082911,
EF2102912-EF2103036, EF2123037-EF2123086,
EF3033037-EF3033106, EF3043107-EF3043126,
EF3053127-EF3053146, EF3063147-EF3063226,
EF3083227-EF3083276, EF3093277-EF3093326,
EF3103327-EF3103406, EF3113407-EF3113486,
EF3123487-EF3123511, EG2041680-EG2041704,
EG2051705-EG2051729, EG2061730-EG2061754,
EG2071755-EG2071779, EG2081780-EG2081879,
EG2111880-EG2111929, EG2121930-EG2121979,
EG3011980-EG3012029, EG3032030-EG3032079,
EG3042080-EG3042179, EG3062180-EG3062229,
EG3092230-EG3092279, EG3102280-EG3102379,
EG3122380-EG3122429;
(g) FA2043634-FA2043645, FA2063646, FA2073647-FA2073649,
FA2083603-FA2083655, FA2093656-FA2093659,
FA2103660-FA2103666, FA2113667-FA2113668,
FA2123671-FA2123677, FA3022678-FA3023695,
FA3033696-FA3033699, FA3043669, FA3063700-FA3063703,
FA3073706-FA3073710, FA3083704-FA3083705, FA3093711,
FA3093724-FA3093727, FA3103712-FA3103714,
FA3113715-FA3113719, FB2052034-FB2052035,
FB2092036-FB2092050, FB3022051-FB3022070;
(h) BA1121102-BA1121104, BA2061101-BA2061112,
BA2071113-BA2071119, BA2081120-BA2081130,
BA2091131-BA2091148, BA2101149-BA2101152,
BA2111153-BA2111155, BA2121156-BA2121161,
BA3021001-BA3021024, BA3031025-BA3031033,
BA3121027-BA3121038.
MANUFACTURER ConMed Corporation, Utica, New York (unprotected lead
wires).
RECALLED BY Neuro Technology, Houston, Texas, by letter June 14, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 128 units; (b) 1,121 units; (c) 11,419 units; (d) 336
units; (e) 858 units; (f) 2,940 units; (g) 122 units; (h)
105 units.
REASON Product labeling fails to provide adequate directions for
use and the lead wires pose an unwarranted risk of injury to
patients, because the electrode lead wires are not labeled
to contraindicate use with apnea monitors.
-13- _______________
PRODUCT Battery cable for Delphin II Centrifugal Pump part 78-8067-
3763-7), the connection between the Delphin II Centrifugal
Pump and its backup battery. Recall #Z-1217-4.
CODE Cables are not coded.
MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by telephone on or about October 6, 1993.
Firm-initiated recall complete.
DISTRIBUTION South Carolina, Minnesota, Ohio, Colorado.
QUANTITY 10 cables were distributed.
REASON Cables were built without the jumper necessary to relay the
battery signal to the digital display and audio alarm
systems of the Delhin II Centrifugal Pump. Due to the
defective cable, there is no screen display or audible alarm
to acknowledge system had switched to backup DC power.
_______________
PRODUCT Austin Moore Fenestrated Modular Hip Stem:
(a) Product #4555-10-01, size Small;
(b) Product #4555-20-01, size Medium
(c) Product #4555-30-01, size Large;
(d) Product #4555-40-01, size Extra Large.
Recall #Z-1218/1221-4.
CODE All lots.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by letter June 2, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,612 hip stems were distributed.
REASON A design change increasing the dimension of the hip stem
along the lateral surface resulted in femur fractures upon
insertion of the product into the body.
_______________
PRODUCT Tanning beds: (a) Model No. 2400 ST, Pro-Performer, 6' Sun
Bed with 24 Cosmolux S Lamps and 20 minute Timer;
(b) Model No. 2410 SEi, Mega-Power, 7' Sun Bed with 24
Staggered Cosmolux S Lamps and 20 minute Timer;
(c) Model No. 2420 SEi, Mega-Power, 7' Sun Bed with 24
Staggered Cosmolux S Lamps and 10 minute Timer;
(d) Model No. 2000 ST, 6' Sun Bed with 20 Cosmolux S Lamps
and 20 minute Timer. Recall #Z-1224/1227.4
CODE All serial numbers through April 1994 production.
MANUFACTURER ESB Enterprises, Inc., Cortland, Illinois.
RECALLED BY Manufacturer, by letter June 8, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 767 beds were distributed.
REASON A capacitor in the subject tanning beds could fail if there
is a voltage surge which could result in smoke or local
flame.
-14- _______________
UPDATE Sterile Ophthalmic solutions for use with contact lenses,
Recall #Z-931/939-4 which appeared in the June 29, 1994
Enforcement Report has been extended to include additional
lot numbers for the following products:
Recall #Z-932-4, Sherman Pharmaceutical Stay-Wet 3 preserved
wetting and "in eye" lubricating solution and rewetting
drops, lot numbers 0484 and 2213;
Recall #Z-935-4, Sherman Pharmaceutical de Stat 3 Cleaning,
disinfection and storage solution, lot #2703;
Recall #Z-939-4, Choongwae Pharma Corp. Sof/Pro-Clean
cleaning solution, lot 0864.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Dial Away Pain 400/Synaptic 1000. Recall #Z-1203-4.
CODE Serial #10392181.
MANUFACTURER HWI, Frederick, Colorado.
RECALLED BY R.F.P., Inc., Aurora, Colorado, by letters of March 4, 1994,
and April 26, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 68 units.
REASON Product specifications do not conform to those listed in its
premarket notification.
-15-
END OF ENFORCEMENT REPORT FOR AUGUST 17, 1994. BLANK PAGES MAY
FOLLOW.
####