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
05/01/1996

ENFORCEMENT REPORT FOR 05/01/96

May 1, 1996 96-18

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Dried Mixed Fruit, in clear ziplock bags,
random weight. Recall #F-490-6.
CODE Individual bags uncoded; master shipping
carton coded with UPC code 29025 and lot
number 19I5.
MANUFACTURER Homa Company, Parsippany, New Jersey.
RECALLED BY Manufacturer, by providing corrective stick-on
labels on or about November 13, 1995. Firm-
initiated field correction (relabeling)
complete. (Product was encountered by the
State of Connecticut, and suspected to contain
undeclared sulfites.)
DISTRIBUTION Connecticut.
QUANTITY 350 cases (25-35 units per case) were
distributed; firm estimates none remains on
the market.
REASON Product contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Individually wrapped process cheese product
slices, packaged under Kraft Foods and various
private labels, 12 packs per case except the
32 slice packs which were packaged 6 packs
per case: (a) American Pasteurized Process Cheese
Spread, under the following labels:
(i) Kraft Velveeta Slices, 16 slices, net
weight 12 ounces; 20 slices, net weight 16
ounces
(ii) Kraft Velveeta Slices, Extra Thick, 10
slices, net weight 12 ounces
(iii) Super 1 Foods, distributed by Super 1
Foods, Tyler, Texas, 16 slices, net weight 12
ounces
(iv) Brookshire's American, distributed By
Brookshire Grocery Co., Tyler, Texas, 16
slices, net weight 12 ounces
(v) Fastco, distributed by Fareway-Boone,
Inc., Boone, Iowa, 16 slices, net weight 12
ounces
(vi) Sherm's, distributed by Sherm's
Thunderbird Discount Market, Inc., Medford,
Oregon, 16 slices, net weight 12 ounces
(b) American Artificially Flavored Nonfat
Pasteurized Process Cheese Product, under the
following labels:
(i) Kraft Free Singles, 32 slices, net weight
24 ounces; 24 slices, net weight 16 ounces; 16
slices, net weight 12 ounces; 10 slices, net
weight 7.5 ounces; Extra Thick, net weight 12
ounces
(ii) Hannaford, distributed by Hannaford Bros.
Inc., Scarborough, Maine, 16 slices, net
weight 12 ounces
(iii) Harris Teeter, distributed by Harris
Teeter, Matthews, North Carolina, 16 slices,
net weight 12 ounces
(iv) Cedarbrook Farms, distributed by Roundy's
Inc., Pewaukee, Wisconsin, 16 slices, net
weight 12 ounces
(v) Quality Fat Free, distributed by Roundy's
Inc., Pewaukee, Wisconsin, 16 slices, net
weight 12 ounces
(vi) Sherm's Fat Free, distributed by Sherm's
Thunderbird Discount Market, Inc., Medford,
Oregon
(c) Kraft Free Singles Mozzarella Artificially
Flavored Nonfat Pasteurized Process Cheese
Product, 16 slices, net weight 12 ounces
(d) Kraft Free Singles Swiss Artificially
Flavored Nonfat Pasteurized Process Cheese
Product, 16 slices, net weight 12 ounces
(e) Kraft Free Singles Sharp Cheddar
Artificially Flavored Nonfat Pasteurized
Process Cheese Product, 16 slices, net weight
12 ounces

-2- (f) Kraft 1/3 Less Fat Swiss Flavor
Pasteurized Process Cheese Product, 16 slices,
net weight 12 ounces
(g) Kraft 1/3 Less Fat Sharp Cheddar Flavor
Pasteurized Cheese Product, 16 slices, net
weight 12 ounces Recall #F-470/476-6.
CODE All use by dates with "C" plant designator.
The recall does not include Velveeta Slices
product with codes after SEP-07-96C and all
Kraft Free Singles product with codes after
JUL-08-96C. Products with a code date
containing the letter "J" are not part of the
recall.
MANUFACTURER Kraft Foods, Inc., Champaign, Illinois.
RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by
telephone on February 15, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 923,704 cases were distributed; firm estimated
that 20% of product remained on market at time
of recall initiation,
REASON A potential defect in the individual slice
plastic inner wrap packaging could leave a
portion of the wrapper on the slice and may
inadvertently cause a choking hazard or be
aspirated.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Fresh Breath Plus Mouthwash, in 4 ounce
plastic bottles. Recall #F-466-6.
CODE Lot numbers: 4562 and 5588.
MANUFACTURER Geritrex Corporation, Mount Vernon, New York.
RECALLED BY Manufacturer, by letter on October 18, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, New York, Pennsylvania, Massachusetts,
Connecticut.
QUANTITY Approximately 15 to 53 cases (96 bottles per
case) of lot 4562; and approximately 15 to 59
cases (96 bottles per case) of lot 5588 were
distributed.
REASON Product is contaminated with Pseudomonas
aeruginosa.

_______________
PRODUCT Quest for Fire brand Hot Sauce, three flavors,
in glass bottles:
(a) Original; (b) XXX; (c) Green.
Recall #F-467/469-6.
CODE All misbranded product.
MANUFACTURER Calido Chile Traders Distribution, Inc.,
Merriam, Kansas.
-3-RECALLED BY Manufacturer, by letter on March 6-7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,958 bottles; (b) 2,288 bottles; (c)
1,577 bottles were distributed.
REASON Misbranding (short weight): The products net
weight statement is labeled as 20 oz., but the
bottle actually contains approximately 12.5
ounces.

_______________
PRODUCT Frozen Concentrated Apple Juice, in 12 ounce
containers, under the Rich Food and Roche
Bros. labels. Recall #F-477-6.
CODE P PO R1N B1 and P PO R1N B2 (Rich Food); P U
R1D B2 (Roche Bros.)
MANUFACTURER Winter Garden Citrus, Winter Garden, Florida.
RECALLED BY Manufacturer, by letter faxed on March 8,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Virginia, Washington D.C., and in the New
England area.
QUANTITY 717 cases (24 units per case) were
distributed.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.

_______________
UPDATE Various Mott's juice products containing apple
juice, Recall #F-384/390-6, which appeared in
the April 17, 1996 Enforcement Report should
read: All product produced between 8/15/95 -
9/13/95.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Cephradine Capsules USP, Rx antibiotic: (a)
250 mg, in bottles of 500,under the Rugby
label; (b) 500 mg, in bottles of 100, under
the Biocraft label. Recall #D-127/128-6.
CODE Lot numbers: (a) 53015 EXP 4/1/96; (b) 53016
EXP 4/1/96.
MANUFACTURER Biocraft Laboratories, Inc., Fairfield, New
Jersey.
RECALLED BY Biocraft Laboratories, Inc, Fairlawn, New
Jersey, by letters on October 6, 1995 and
November 10, 1995. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY (a) 504 bottles; (b) 5,467 bottles were
distributed; firm estimated that less than 5
percent of product remained on market at time
of recall initiation.
-4-REASON Potency not assured through expiration date.

_______________
PRODUCT Alupent (metaproterenol sulfate), USP,
Inhalation Aerosol Refill, 200 metered doses,
Rx bronchodilator. Recall #D-129-6.
CODE Lot #951051A EXP 9/97.
MANUFACTURER 3M Pharmaceuticals, Northridge, California.
RECALLED BY Boehringer Ingelheim Pharmaceuticals, Inc.,
Ridgefield, Connecticut, by fax and press
release on April 9, 1996, followed by letter
dated April 12, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,413 canisters were distributed.
REASON A single unit of Atrovent aerosol was found
within lot 951051A.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Niferex Forte Elixir, Rx in 4 ounce bottles,
indicated for iron deficiency anemia.
Recall #D-130-6.
CODE All lots, which includes the following lot
numbers:
"EES", expiration 12/95
"ENL", expiration 04/96
"GLW", expiration 06/96
"GUH", expiration 11/96
"HSL", expiration 01/97
"HUJ", expiration 04/97
"KYU", expiration 04/97
"JAK", expiration 05/97
"LCT", expiration 06/97
"JUR", expiration 08/97
"KAU", expiration 11/97
"KGZ", expiration 01/98
"KKN", expiration 01/98.
MANUFACTURER Central Pharmaceuticals, Inc., Seymour,
Indiana.
RECALLED BY Manufacturer, by letter mailed on December 29,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Haiti.
QUANTITY Firm estimates none remains on the market.
REASON Subpotency of Vitamin B12 ingredient.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Extended Stay Stretchers and Warming
Stretchers:

-5- (a) Stryker Medical Thermaltek Series
Emergency Care Warming Stretcher, Model 1030;
(b) Stryker Medical Thermaltek Series PACU
Warming Stretcher, Model 1530;
(c) Stryker Patient Handling Synergy Series
Extended Stay Stretcher, Model 1050;
(d) Stryker Patient Handling Synergy Series
Extended Stay Stretcher, Model 1550.
Recall #Z-542/545-6.
CODE All stretchers manufactured between June 1993
and September 1995 with serial numbers 9306
through 9312, 9401 through 9412, or 9501
through 9509.
MANUFACTURER Belden Wire & Cable Company, Cord Products
Division, Carmel, Indiana (power cords);
Stryker Medical, Division of Stryker
Corporation, Kalamazoo, Michigan (stretchers).
RECALLED BY Stryker Patient Handling, Kalamazoo, Michigan,
by letter sent on December 4, 1995. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada, Colombia, The Netherlands,
Singapore.
QUANTITY 949 stretchers were distributed.
REASON The outer casings of the power cords on these
electrical powered stretchers are cracking
because the insulation used on the outer
jacket was not compatible with the insulation
used on the inner conductors.

_______________
PRODUCT MEVASIM and MEVASIM 'S' Radiation Therapy
Simulator Systems, a medical linear
accelerator used for the treatment of
superficial, shallow and deep seated tumors.
Recall #Z-585-586-6.
CODE MEVASIM Radiation Therapy Simulator Systems,
with Lot Nos. 217, 1002-1086 (inclusive),
1099, 1579, 1972; and
MEVASIM 'S' Radiation Therapy Simulator
Systems, with Lot Nos. 1001, 1101-1128
(inclusive), 1130-1265 (inclusive), 1501-1524
(inclusive).
MANUFACTURER Mecaserto Radiotherapie, France.
RECALLED BY Siemens Medical Systems Oncology Care Systems,
Concord, California, by letters mailed on or
about June 14, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 279 units were distributed.

-6-REASON The MEVASIM and MEVASIM 'S' film grid
assemblies have the potential to fall from the
cassette holder when the gantry is rotated to
the lateral position, and the MEVASIM 'S'
field collimating blades have the potential of
slowly drifting when the gantry is in the
lateral position.

_______________
PRODUCT Vericord VS3 Radiotherapy Verification and
Record System, used with Model SL 75/5 Linear
Accelerators, used to treat superficial
shallow and deep seated tumors.
Recall #Z-587-6.
CODE All software versions up to and including
2.2.1.
MANUFACTURER Philips Medical Systems, Crawley, West Sussex,
England.
RECALLED BY Philips Medical Systems, Shelton, Connecticut,
by letter December 18, 1995. Firm-initiated
field correction ongoing.
DISTRIBUTION Florida, New Jersey, Ohio, Pennsylvania,
Canada.
QUANTITY 16 units were distributed.
REASON Software version 2.2.1 does not commence
recording of dose information at the beginning
of beam delivery from the SL 75/5 linear
accelerators.

_______________
PRODUCT Genesis II Resuscitators:
(a) Genesis II Adult/Child Automatic
Time/Volume Cycled Resuscitator with Masks,
Part #155020-OT
(b) Genesis II Adult Only Automatic
Time/Volume Cycled Resuscitator with Mask,
Part No. 155021-OT
(c) Genesis IDLH Automatic Time/Volume Cycled
Resuscitator with Masks, Part No. 155022-OT,
(d) First Response Kit (which contains Genesis
II Adult/Child Resuscitator with Mask), Part
No. 155025-OT. Recall #Z-597/600-6.
CODE Serial numbers: (a) PB50005-PB50199; (b)
PB60074; (c) PB80015 and PB80022; (d) The
serial number is found on the resuscitator
inside the kit, which would be Part No.
155020-OT and would bear one of the serial
numbers listed for that part number above.
MANUFACTURER O-Two Systems International, Inc.,
Mississauga, Ontario, Canada.

-7-RECALLED BY Nellcor Puritan Bennett, Lenexa, Kansas, by
telephone January 8-9, 1996, followed by
electronic mail message dated January 26,
1996, and by letter dated February 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Iowa, Massachusetts, Alabama,
California, Mexico, Peru, Ireland, United
Kingdom.
QUANTITY 168 units were distributed.
REASON The flapper valve of the actuating diaphragm
of the demand valve had been partially sucked
into the diaphragm insert, causing the
automatic shutoff valve to function, thereby
shutting off all flow through both manual and
automatic circuits.

_______________
PRODUCT Natural Knee Tibial Insert, used in
conjunction with Intermedics' Natural Knee
System to replace a diseased or otherwise
dysfunctional knee joint:
(a) Natural Knee Size A, Congruent Tibial
Insert W/Screw, Left, 11 mm - Catalog No.
6200-05-811
(b) Natural Knee Size A, Ultra Congruent
Tibial Insert W/Screw, Right, 22 mm - Catalog
No. 6250-01-722. Recall #Z-608/609-6.
CODE Lot numbers: (a) 122023; (b) 1219984,
MANUFACTURER Intermedics Orthopedics, Inc., (IOI), Austin,
Texas.
RECALLED BY Manufacturer, by telephone on March 18, 1996,
followed by letter dated March 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Florida, Michigan,
Mississippi, Ohio, Pennsylvania, Tennessee,
Texas, Wisconsin.
QUANTITY (a) 7 units; (b) 9 units were distributed.
REASON A package labeled as an 11 mm left congruent
insert actually contained a 22 mm right ultra
congruent insert.

_______________
PRODUCT ERCP (Endoscopic Retrograde
Cholangiopancreatography) Cannulas, diagnostic
devices:
(a) Product No. 250-021-1
(b) Product No. 250-021-B
(c) Product No. 251
(d) Product No. 251-021-1
(e) Product No. 251-021-B
(f) Product No. 251-B
(g) Product No. 250-WB-021

-8- (h) Product No. 252
(i) Product No. 252-B
(j) Product No. 253
(k) Product No. 253-B
(l) Product No. 257
(m) Product No. 257-B
(n) Product No. 258
(o) Product No. 258-B. Recall #Z-612/626-6.
CODE Lot numbers: (a) 61692-922 to 4181-139;
(b) 62992-924 to 4181-139;
(c) 03092-911 to 4181-139;
(d) 1011-975 to 4181-139;
(e) 1011-975 to 4181-139;
(f) 060892-924 to 4181-139;
(g) 2453-106 to 4181-139;
(h) 111191-5618 to 4181-139;
(i) 1176-985 to 4181-139;
(j) 20192-945 to 4181-139;
(k) 1228-982 to 4181-139;
(l) 2180-103 to 4181-139;
(m) 2180-103 to 4181-139;
(n) 20492-945 to 4181-139;
(o) 20492-945 to 4181-139.
MANUFACTURER Mill-Rose Laboratories, Inc., Mentor, Ohio.
RECALLED BY Manufacturer, by letter dated November 8,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,394 cannulas were distributed.
REASON The depth markings on the cannula tip slough-
off into the patient during invasive surgical
procedures.

_______________
PRODUCT Starplex 60 ml Jr. Leakbuster Sterile Specimen
Container, Catalog No. B602L.
Recall #Z-629-6.
CODE Lot Nos. 4A__ to 4M__ and 5A__ to 5F30.
MANUFACTURER Starplex Scientific, Etobicoke, Ontario,
Canada.
RECALLED BY Laboratory Product Sales, Rochester, New York,
by telephone and by letter faxed on July 20,
1995. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY Undetermined.
REASON Some of the lots in distribution had not been
irradiated with the correct dose.

_______________
PRODUCT Abiomed BVS 5000 Bi-Ventricular Support
System-Solenoid Valve in BVS Console,

-9- Catalog #0005-0000, a mechanical circulatory
support system for use in patients suffering
from postcardiotomy ventricular dysfunction.
Recall #Z-630-6.
CODE Console serial numbers: 1203-1269, 1271-1295,
1016, 1019, 1029, 1062, 1063, 1072, 1091,
1093, 1118, 1122-1125, 1130, 1133, 1140, 1143,
1144, 1146, 1154, 1166, 1167, 1171, 1175,
1182, 1186, 1196, 1197.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter on March 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 139 valve assemblies (2 valves in each
assembly) are in commerce.
REASON The solenoid valves used in the BVS console
are failing in the closed position causing
"Low Pressure, Low Flow" alarms to activate.

_______________
PRODUCT Laser Treatment Systems, used for hair
removal: Recall #Z-631-6.
CODE Model LT100.
MANUFACTURER Lorad Corporation, Danbury, Connecticut.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan April 16, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9 units.
REASON The devices failed to comply with 21 CFR
1040.11(a)(2) in that the Operator's Manuals
lacked adequate calibration procedures and
calibration schedule.

_______________
PRODUCT Corflo 300 Enteral Feeding Pump, a volumetric
rotary peristaltic intermittent pump designed
for both adult and pediatric enteral feeding.
Recall #Z-634-6.
CODE Serial numbers: C00027, C00032, C00033,
C00042, C00053, C00072, C00093, C00102,
C00171, C00176, C00179, C00186, C00187,
C00189, C00196, C00199, C00200, C00201,
C00202, C00205, C00212, C00213, C00219,
C00221, C00224, C00227, C00230, C00231,
C00233, C00234, C00235, C00237, C00242,
C00244, C00247, C00249, C00251, C00252,
C00253, C00264, C00266, C00270, C00273,
C00274, C00275, C00279, C00280, C00282,
C00284, C00286, C00290, C00291, C00298,
C00299, C00316, C00335, C00342, C00349,
C00364, C00365, C00367, C00370, C00371,

-10- C00376, C00377, C00387, C00391, C00394,
C00395, C00396, C00397, C00403, C00406,
C00411, C00414, C00419, C00421, C00422,
C00436, C00438, C00439, C00440, C00446,
C00449, C00451, C00453, C00454, C00455,
C00457, C00459, C00487, C00491, C00492,
C00493, C00498, C00499, C00504, C00509,
C00508, C00512, C00513, C00520, C00522,
C00523, C00532, C00540, C00542, C00543,
C00546, C00547, C00551, C00552, C00554,
C00560, C00572, C00576, C00582, C00585,
C00599, C00600, C00605, C00607, C00623,
C00641, C00643, C00647, C00654, C00659,
C00660, C00668, C00673, C00678, C00679,
C00684, C00693, C00694, C00696, C00701,
C00708, C00716, C00717, C00723, C00724,
C00726, C00727, C00729, C00733, C00734,
C00735, C00743, C00745, C00747, C00753,
C00756, C00759, C00760, C00761, C00762,
C00764, C00765, C00766, C00768, C00770,
C00771, C00773, C00774, C00778, C00781,
C00782, C00783, C00785, C00788, C00789,
C00791, C00793, C00794, C00795, C00796,
C00803, C00821, C00833.
MANUFACTURER Corpak MedSystems, Wheeling, Illinois (pump);
Illini Technology, Inc., Springfield, Illinois
(PC board stuffer); Atmel Corporation, San
Jose, California (IC chip).
RECALLED BY Corpak MedSystems, Wheeling, Illinois, by
letters dated March 27, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 181 pumps were distributed, with the firm
estimating that all of the units remain on the
market.
REASON Some of the devices may have defective IC
chips which may cause the pump to malfunction.

_______________
PRODUCT Mitochondria EIA Test Kit, for in-vitro
diagnostic use, Catalog No. 2338370.
Recall #Z-635-6.
CODE Lot numbers: 2338370-01 EXP 10/95,
2338370-01E EXP 4/96.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by letter dated March 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Maryland, Pennsylvania, Tennessee,
international.
QUANTITY 64 kits were distributed.
REASON The product insert packaged with the kits
stated an incorrect length of time to run the
test.
-11-_______________
PRODUCT Rolls brand Manual Wheelchairs: (a) Model
2000 Series; (b) Model 9000 Series.
Recall #Z-636/637-6.
CODE Serial numbers beginning with 95G through
numbers beginning with 95H.
MANUFACTURER Invacare Corporation, North Ridgeville, Ohio.
RECALLED BY Manufacturer, by telephone on October 19,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 118 chairs were distributed.
REASON The front steel caster forks, which support
the chair wheels, have the potential for
buckling under stress which could cause the
chair to tip over and the user to potentially
fall out of the wheelchair.

_______________
PRODUCT Various Custom Procedure Trays containing
BARRIER* Vu-Thru Cardiovascular Split Sheet,
labeled with a unique work order number, used
for various procedures ranging from general
surgery to open heart surgery.
Recall #Z-647/695-6.
CODE Catalog #26-SMH09SF, Work Order #5039470;
Catalog #27-SMH09SF, Work Order #5040853;
Catalog #28-SMH09SF, Work Order #5041439;
Catalog #82-LIJMC02NY, Work Order #5037175;
Catalog #83-LIJMC02NY, Work Order #5039116;
Catalog #84-LIJMC02NY, Work Order #5040456;
Catalog #84-EH01PP, Work Order #5038809;
Catalog #85-EH01PP, Work Order #5044151;
Catalog #50-AH02AV, Work Order #5040784;
Catalog #62-EMMC06BM, Work Order #5042317;
Catalog #63-EMMC06BM, Work Order #5044320;
Catalog #03-AH01AVA, Work Order #5040151;
Catalog #04-AH01AVA, Work Order #5041958;
Catalog #47-BMC120CO, Work Order #5041139;
Catalog #48-BMC120CO, Work Order #5042403;
Catalog #49BMC120OC, Work Order #5043817;
Catalog #17-HEB01BT, Work Order #5039454;
Catalog #18-HEB01BT, Work Order #5040839;
Catalog #19-HEB01BT, Work Order #5042026;
Catalog #20-HEB01BT, Work Order #5043538;
Catalog #23-SMC22SAT, Work Order #5039396;
Catalog #24-SMC22SAT, Work Order #5039806;
Catalog #25-SMC22SAT, Work Order #5040145;
Catalog #26-SMC22SAT, Work Order #5040472;
Catalog #27-SMC22SAT, Work Order #5040944;
Catalog #02-MH01BHM, Work Order #5047813;
Catalog #02-SJHK43KM, Work Order #5035748;
Catalog #03-SJHK43KM, Work Order #5035749;

-12- Catalog #04-SJHK43KM, Work Order #5038961;
Catalog #13-SJ13SI, Work Order #5034921;
Catalog #14-SJ13SI, Work Order #5035601;
Catalog #15-SJ13SI, Work Order #5036344;
Catalog #16-SJ13SI, Work Order #5036899;
Catalog #17-SJ13SI, Work Order #5037524;
Catalog #18-SJ13SI, Work Order #5038812;
Catalog #37-SJ17SI, Work Order #5035742;
Catalog #38-SJ17SI, Work Order #5041592;
Catalog #47-SFH09BGI, Work Order #5044209;
Catalog #87-SJMC02FWI, Work Order #5038075;
Catalog #88-SJMC02FWI, Work Order #5040008;
Catalog #90-DCH01DC, Work Order #5039712;
Catalog #91-DCH01DC, Work Order #5041741;
Catalog #52-HH01WHC, Work Order #5039121;
Catalog #42-SCMC02BO, Work Order #5040465;
Catalog #43-SCMC02BO, Work Order #5041672;
Catalog #44-SCMC02BO, Work Order #5042406;
Catalog #45-SCMC02BO, Work Order #5043819;
Catalog #14-SJH12BW, Work Order #5039805;
Catalog #15-SJH12BW, Work Order #5041755.
MANUFACTURER Maxxim Medical, doing business as Sterile
Design, Clearwater, Florida.
RECALLED BY Manufacturer, by letters dated December 17,
1995 and December 8, 1995. Firm-initiated
recall complete.
DISTRIBUTION California, Pennsylvania, Florida, Michigan,
Texas, Oklahoma, Virginia, Illinois, Missouri,
New York, Washington state, Oregon, Indiana,
Maryland, New Jersey, Illinois.
QUANTITY 803 trays were distributed.
REASON The fabric of the clipping tabs of the split
sheet are subject to tearing which may result
in unsecured lines.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT DRS 4 Dialyzer Reprocessing System EPROM ESIO
software version SXD329.OPO, found in the DRS4
D models, used to clean and disinfect single
use dialyzers for multiple use.
Recall #Z-627-6.
CODE Various serial numbers with software version
SXD329.OPO.
MANUFACTURER Fresenius USA, Inc., Walnut Creek, California.
RECALLED BY Seratronics, Inc., Walnut Creek, California,
by visits beginning May 11, 1995, and
completed on May 31, 1995. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 39 units were distributed.

-13-REASON A flaw in the software may cause the machine
to lock-up during self-test upon power-up.

_______________
PRODUCT Dulbecco's Phosphate Buffered Saline (DPBS),
in 500 ml and 1000 ml bottles, sterile, for
cell culture/in-vitro diagnostic use.
Recall #Z-628-6.
CODE Catalog #59300-OCS, Lot #5M3642 EXP 6/1/97.
MANUFACTURER JRH Biosciences, Lenexa, Kansas.
RECALLED BY Manufacturer, by letter dated March 26, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Virginia, Connecticut, New Jersey,
Massachusetts, Maryland, Pennsylvania, Texas.
QUANTITY 306 500-ml and 4 1000-ml bottles were
distributed.
REASON The above lot of material may have units which
do not contain Dulbecco's Phosphate Buffered
Saline but contain water.

_______________
PRODUCT Daily Wear Polymacon Soft (Hydrophilic)
Contact Lenses. Brand names include
Ultraflex, CQ-4, Edge III Optiflex, Proflex,
Neoflex, Mediflex, Clinasoft, Polysoft,
OPTICA, Aqualens, Optiform, OPTIVIEW, Softech,
and Procon. Recall #Z-633-6.
CODE Lot/Serial Numbers: Lot #94XX00774508, where
the "XX" can be any number.
MANUFACTURER OSI Corporation, San Francisco, California.
RECALLED BY Manufacturer, by letter November 22, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,159 units were distributed; firm estimated
that 1,245 units remained in commerce as of
December 1995.
REASON The lenses are labeled as "polymacon, 38%
water," when they may, in fact, be "ocufilcon
D, 55% water."

_______________
PRODUCT ECTRA Retrograde Knives packaged as follows:
(a) ECTRA II Disposable Procedure Kit
(Sterile) Part No. 4116;
(b) ECTRA II Disposable Retrograde Knife, Part
No. 4449. The ECTRA II System is indicated
for the relief of Carpal Tunnel Syndrome.
Recall #Z-638/639-6.
CODE Lot numbers: (a) 312534, 312535, 312536,
312827, 312966, 313275, 313527, 313742,
313927, 313928, 314152, 314275, 314317,
314562, 314563, 314863, 314936;

-14- (b) 312654, 312829, 313741, 314153, 314565,
314566, 314865.
MANUFACTURER Smith & Nephew Endoscopy, Andover,
Massachusetts.
RECALLED BY Manufacturer, by letter issued March 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 4,300 units remained in
distribution at time of recall initiation.
REASON The tips are subject to breakage during use.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
========
_______________
PRODUCT Atropine Sulfate 1/120 Solution, in 100 ml
bottles, a preanesthetic for dogs and cats.
Recall #V-014-6.
CODE Lot numbers: 3476, 3693, 3723, 3750.
MANUFACTURER Gen/Rx, Fort Collins, Colorado.
RECALLED BY Manufacturer, by letters dated March 29, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Florida, Iowa,
Kansas, Missouri, Nebraska, New York, Ohio,
South Carolina, Texas, Wisconsin.
QUANTITY 32,864 bottles were distributed.
REASON Product below specifications. Potency cannot
be assured until the expiration.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
_______________
PRODUCT Cal-Pho-Sol Solution, in 100 ml bottles, used
as an aid in the treatment of canine
eclampsia. Recall #V-015-6.
CODE Lot #3566.
MANUFACTURER Gen/Rx, Fort Collins, Colorado.
RECALLED BY Manufacturer, by letter dated February 26,
1996. Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Iowa, Missouri.
QUANTITY 1,164 bottles were distributed.
REASON Product is out of specifications for
phosphorus.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Landmark Midline Catheter, a venous access
device designed for peripheral infusion of
general IV therapy solutions and blood
sampling. Safety Alert #N-011-6.
CODE All lots.
MANUFACTURER Menlo Care, Inc., Menlo Park, California.

-15-ALERTED BY Manufacturer, by letter dated January 12,
1996.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 726,000 units were distributed.
REASON There is a potential for patient adverse
reactions when using this device. These
reactions can range from minor signs and
symptoms to rare life-threatening incidents.

-16-

END OF ENFORCEMENT REPORT FOR MAY 1, 1996. BLANK PAGES MAY FOLLOW.

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