Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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December 12, 2007
07-50

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
38% Soy milk or 43% Soy milk; 2006 Harvest Vintage Plantations; Net Weight 100g (3.5 oz); Processed at the plantation in Ecuador; Ingredients: pure cocoa mass, pure sugar cane, soy lethithin. No vanilla or aroma added. Chocolate may contain traces of nuts, UPC 797148000398, Recall # F-055-8
CODE
Lot 180906
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Chocolates, Elizabeth, NJ, by fax and telephone on October 2, 12 and 15, 2007, and by press release on October 10, 2007.
Manufacturer: CIA. ECUAT. PRODUC. ELABORADOS DE COCOA C.A. ECUACOCOA, Guayaquil, Ecuador. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
4455 x 100 g bars
DISTRIBUTION
Nationwide, Canada, The Netherlands, England and Sweden
___________________________________
PRODUCT
a) Shain's of Maine Kahlua Brownie Ice Cream Kahlua flavored Ice cream with fudge
brownie chunks Quarts, 3 gallon, Recall # F-057-8;
b) Shain’s of Maine Double Fudge Brownie Ice Cream 3 gallon, Recall # F-058-8
CODE
All codes
RECALLING FIRM/MANUFACTURER
Shain's, Inc. Sanford, ME, by telephone and letters on October 18, 2007. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg and wheat.
VOLUME OF PRODUCT IN COMMERCE
3,236 units
DISTRIBUTION
NH, MA, ME

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Ketoconazole Shampoo, 2%, Rx only, 4 fl. oz., For topical application only, NDC 0781-7090-04, ANDA 76-942, Recall # D-062-2008
CODE
Lot: 2472.
RECALLING FIRM/MANUFACTURER
Tolmar, Inc., Fort Collins, CO, by telephone and letter on November 9, 2007. Firm initiated recall is ongoing.
REASON
Stability testing indicates product will be out of specification by 12 month time point (Subpotent)
VOLUME OF PRODUCT IN COMMERCE
9,348 units
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Penicillin G Procaine, Injectable Suspension, 1,200,000 units per 2mL, Rx only, packages of 10 and individual syringes, Recall # D-057-2008
CODE
Lot number: 44175, exp 03-2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc, Bristol, TN, by letter on October 12, 2007
Manufacturer: King Pharmaceuticals, Inc. Rochester, MI, Firm initiated recall is ongoing.
REASON
Outer carton mislabeling.
VOLUME OF PRODUCT IN COMMERCE
16,660 units (in packages in 10 syringes)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Equate® brand Stimulant Laxative Tablets, Bisacodyl, USP, 5mg, packaged in blister
    packs, 25 tablets/retail pack, 24 packs/case, Delayed-release Tablets,
    NDC 0132-0712-25. Recall # D-058-2008;
b) Fleet® brand Prep Kit #1, Catalog #101, contains 1 bottle Fleet Phospho-soda,
    Sodium Phosphates Oral Solution, USP 1.5 FL OZ (45mL), 4 Fleet Bisacodyl
    delayed-release tablets USP, 5mg each and 1 Fleet Bisacodyl Suppository 10mg
    Bisacodyl USP, packaged in papercard display boxes, 48 boxes/case, case UPC
    10301320001010, Recall # D-059-2008;
c) Fleet® Prep Kit #2, Catalog #210, contains 1 bottle Phospho-soda® Sodium
    Phosphate Oral Solution, USP, 1.5 FL OZ (45mL), 4 Bisacodyl delayed-release
    tablets USP and 1 Bagenema, packaged in papercard display boxes, 48 boxes/case,
    UPC 10301320210016, Recall # D-060-2008;
d) Fleet® Prep Kit #3, Catalog #103, contains 1 bottle Phospho-soda®, 4 Bisacodyl
    delayed-release tablets USP, 5mg each and 1 Bisacodyl Enema, 10mg Bisacodyl
    USP, packaged in papercard display boxes, 48 boxes/case, UPC 10301320001034,
    Recall # D-061-2008
CODE
a) Equate® brand Lot numbers: E10032, E10033, E10034, El0034A, E10035,
E10035A, E10036, E10037, E10037A, E10038, E10039, E10040, E10040A, E10041, E10042, E10042A, E10043, E10044, E10045, E10046, E10046A, E10047, E10047A, E10048, E10048A, E10049, E10050, E10051, E10052, E10052A, E10053, E10053A, E10054, E10055, E10055A, E10056, E10057, E10057A, E10058, E10059, E10060, E10060A, E10061, E10061A, E10062, E10062A, E10063, E10064, E10064A, E10064B, E10065, E10066, E10067, E10067A, E10068, E10068A ---- Fleet® brand Lot numbers: A10028, A10029, A10030, A10031, A10033, A10034, A10035, A10036, A10036A, A10037, A10038, A10039, A10040, A10041, A10042, A10043, A10044, A10045, A10046, A10046A, A10047, A10048, A10049, A10049A, A10050, A10050A, A10051, A10052, A10053;
b) Fleet Prep Kit #1, Lot Numbers: 0719413, 0718709, 0717030, 0716620, 0713608,
0709307, 0705802, 0703915, 0702239, 0701734, 0701199, 0700819, 0636107L, 0634741L, 0634517L, 0632418L, 0632143L, 0630527L, 0629631, 0627810, 0626322, 0623734, 0621345, 0619405, 0615358, 0613819, 0611620, 0609529, 0607627, 0606528, 0603718, 0601902, 0536305, 0536301, 0533926, 0531106, 0529129, 0528704, 0528104, 0523414, 0521803, 0520601, 0519936, 0516204, 0513914, 0511724, 0507641;
c) Fleet Prep Kit #2 Lot Numbers: 0717715, 0613820L, 0611023L, 0624001L,
     0616529L, 0623512L, 0624001, 0623512, 0616529, 0613820, 0611023, 0606117,
     0604831, 0601212, 0534710, 0531935, 0531816, 0528703, 0527603, 0522817,
     0518111, 0514512, 0511721;
d) Fleet Prep Kit #3 Lot Numbers: 0719009, 0717113, 0713131, 0606832L, 0621635L,
    0624018L, 0629330L, 0701926, 0634736L, 0632509L, 0629330, 0630503L, 0624018,
    621635, 0613119, 0606832, 0603457, 0601152, 0535542, 0535521, 0530604,
    0528702, 0523721
RECALLING FIRM/MANUFACTURER
C B Fleet Company Incorporated, Lynchburg, VA, by letter dated August, 28, 2007. by letter on August 28, 2007. Firm initiated recall is ongoing.
REASON
Failed USP Disintegration Test Requirements.
VOLUME OF PRODUCT IN COMMERCE
351,738 cases
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I
___________________________________
PRODUCT
a) Baxter Closed System Apheresis Kit with PL 3014 Plastic Platelet Storage Containers;
    an Rx disposable sterile fluid pathway for platelet and plasma collection; catalog
    number 4R2180T, Recall # B-0152-08;
b) Baxter Fenwal Open System Apheresis Kit; an Rx disposable sterile fluid pathway
    for blood component collection; catalog number 4R2210T, Recall # B-0153-08;
c) Baxter Fenwal Closed System Apheresis Kit with restrictor tubing; an Rx disposable
    sterile fluid pathway for platelet and plasma collection; catalog number R4R2230T
    (multi-language label), Recall # B-0154-08;
d) Baxter Fenwal Open System Apheresis Kit with restrictor tubing; an Rx disposable
    sterile fluid pathway for blood component collection; catalog number R4R2210T,
    Recall # B-0155-08
CODE
a) Lot numbers N06D17034, N06D24022, N06D26027, N06E16025, N06E22023,
    N06F12022, N06F15017, N06H17027, N06H29022, N06I01029, N06I05020,
    N06I11028, N06I14014, N016I25028, N06J05011, N06J09021, N06J18022,
    N06J24012, N06J30019, N06K02024, N06K20026, N06K27039, N06L01024,
    N06L13029, N06L20016, N07A22013, N07A24027, N07B07020, N07B13028,
    N07C07028, N07C09016, N07C23025, N07D18015 *** N06A26023 ***;
b) Lot numbers N0521023, N05C01031, N05C06020, N05D12028, N05D15021,
    N05D20021N05E23022, N05E26025, N05F06017, N05F08021, N05F10027,
    N05G12021, N05G15024, N05J27024, N06A11025, N06A13021, N06A18020,
    N06B02022, N06B06023, N06B08029, N06B16022, N06C01022, N06C06021,
    N06C20022, N06C23026, N06C27027, N06D10021, N06E04021, N06E08022,
    N06F05018, N06G22029, N06G27028, N06G28034, N07A09010, N07B22011,
    N07C19023, N07C30020, N07D26018, N07D30010, N07E03014, N07E07023,
    N07E10027, N07E14037;
c) Lot numbers: N06A30017, N06C29023, N06F21023, N06G19025, N06H03027,
    N06H09024, N06J03024, N06K08021, N07B15015, N07B19025, N07D11010;
d) Lot numbers: N05F22022, N06I21027, N06K13039, N07B21013, N07D13016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Round Lake, IL, by telephone on June 20, 2007, and July 25, 2007 and by letters dated June 21, 2007 and July 10, 2007 and July 25, 2007.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, San German, PR. Firm initiated recall is ongoing.
REASON
Some of the CS3000 apheresis kits may have the ACD (anticoagulant) and saline lines misassembled. The reversed bag connections may not be visually apparent and could result in excessive ACD infusion and severe injury, including death, to the donor.
VOLUME OF PRODUCT IN COMMERCE
92,761 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0090-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0091-08;
c) Blood and Blood Products for Reprocessing, Recall # B-0092-08
CODE
a) Unit: 4056551;
b) Units: 0237016; 4030291;
c) Units: 4056551; 0237016; 4030291
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by letter dated June 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL, NC, SC, and AL
___________________________________
PRODUCT
a) Platelets, Recall # B-0189-08;
b) Fresh Frozen Plasma, Recall # B-0190-08
CODE
a) and b) Units: LR70489
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by letter dated April 24, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information regarding multiple high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0250-08
CODE
Unit: 71X453577
RECALLING FIRM/MANUFACTURER
Lifesouth Community Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on August 22, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0279-08
CODE
Unit: 71X391743
RECALLING FIRM/MANUFACTURER
Lifesouth Community Centers, Wiregrass Region, Dothan, AL, by facsimile on October 12, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0280-08
CODE
Unit: 003LJ38759
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by facsimile on October 23, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0361-08;
b) Platelets, Leukocytes Reduced, Recall # B-0362-08
CODE
a) and b) Unit: 027KJ21267
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic notification on May 10, 2007 and by letters dated May 14, 2007 and June 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, NC, and CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0363-08
CODE
Unit: 027KJ21267
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic notification on May 10, 2007 and by letters dated May 14, 2007 and June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, NC, and CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
CODE
Lot Number: 395450.
RECALLING FIRM/MANUFACTURER
Biomet, Inc. Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
REASON
Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift, Recall # Z-0261-2008
CODE
all serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc. Roselle IL, by letter on October 15, 2007.
Manufacturer: Arjo Hospital Equipment, Esloev, Sweden. Firm initiated recall is ongoing.
REASON
Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
VOLUME OF PRODUCT IN COMMERCE
1,279 chairs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Straumann Palatal Implant, 04.1 L 4.2 mm, Article Number: 042.335S,
    Recall # Z-0277-2008;
b) Straumann Palatal Implant, 4.8 L 4.2 mm, Article Number: 042.336S,
    Recall # Z-0278-2008
CODE
a) Lot Numbers: 1001, F3776, F4662, F6563, E7083;
b) Lot number: 1001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann USA LLC, Andover, MA, by letters on September 28, 2007
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
Sticking Transfer Piece. The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
VOLUME OF PRODUCT IN COMMERCE
90 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No.
    801040, Recall # Z-0321-2008;
b) Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No.
    801041, Recall # Z-0322-2008
CODE
a) Serial Numbers: 2110 through 2125;
b) Serial Numbers: 2135 through 2149 and 2230 through 2290
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
REASON
Failure to Operate: The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.
VOLUME OF PRODUCT IN COMMERCE
92 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number: 801046, Recall # Z-0323-2008
CODE
Serial numbers 0020 through 0041, 0043, 0044, 0046 through 0060, 0062 through 0091, 0094, 0098, 0118 through 0137, 0139 through 0156, 0159 and 0166 through 0176
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
REASON
Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Boston Scientific Accustick II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF, Recall # Z-0328-2008
CODE
Lot /Batch Number: 9498023
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, Spencer, IN, by letter on July 19, 2007. Firm initiated recall is complete.
REASON
Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
VOLUME OF PRODUCT IN COMMERCE
249 (199 U.S. plus 50 international)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Allura Xper FD20 X-Ray System, Release 2.2, Recall # Z-0329-2008;
b) Allura Xper FD20/10, Release 1.2, Recall # Z-0330-2008
CODE
    Serial numbers: 778, 779, 777, 746, 848, 647, 754, 612, 609, 677, 852, 853, 929, 821,
    535, 731, 521, 906, 905, 710, 961, 599, 822, 823, 752, 513, 622, 984, 314, 426, 923,
    518, 716, 788, 840, 924, 908, 520, 642, 638, 604, 532, 470, 21, 894, 641, 892, 953,
    895, 560, 559, 970, 587, 654, 588, 742, 741, 790, 785, 930, 913, 700, 655, 39, 907,
    857, 847, 737, 667, 668, 476, 919, 686, 121, 523, 592, 893, 750, 468, 582, 780, 697,
    813, 863, 851, 512, 942, 943, 681, 729, 753, 593, 842, 841, 694, 800, 43090, 637,
    676, 828, 914, 467 / 307, 545, 626, 627, 810, 625, 663, 596, 790, 912, 960, 827, 702,
    825, 776, 777, 774, 722, 478, 888, 248, 683, 628, 616, 606, 723, 485, 775, 43080,
    618, 701, 664, 706, 591, 601, 776, 772, 771, 773, 225, 806, 730, 860, 615, 611, 315,
    707, 797, 921, 623, 672, 675, 674, 765, 896, 680, 816, 679, 691, 751, 786, 514, 673,
    886, 439, 804, 705, 685, 678, 850, 595, 785, 234, 658, 491, 968, 738, 843, 586, 651,
    920, 976, 770, 849, 477, 634, 671, 661, 528, 882, 878, 167, 670, 782, 759, 830, 766,
    718, 722, 709, 689, 861, 933, 469, 959, 903, 632, 602, 303, 692, 22, 9, 862, 808,
    829, 649, 845, 744;
b) Serial numbers: 32, 22, 23, 33, 18, 19, 34, 82, 106, 38, 142, 24, 126, 102, 54, 99,
    112, 68, 74, 73, 56, 84, 141, 52, 36, 67, 71, 108, 69, 100, 113, 103, 116, 94, 133, 125
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Bothell, WA, by letter dated September 21, 2007.
Manufacturer: Philips Medical Systems Netherlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Inaccurate anatomical measurements when using the optional SmartMask feature.
VOLUME OF PRODUCT IN COMMERCE
255 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High Energy Medical
    Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel
    Positioners, Recall # Z-0380-2008;
b) Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle
    radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners,
    Recall # Z-0381-2008;
c) Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation
    therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0382-2008;
d) Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle
    radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
    Recall Z-0383-2008;
e) Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge
    particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
    Recall Z-0384-2008
CODE
a) Serial numbers 3672 3675 3695 3727 3728 3751 3773 2931 2941 3002 3042 3068
    3158 3191 3212 3244 3257 3273 3276 3382 3406 3407 3418 3424 3443 3489 3492
    3504 3515 3516 3547 3564 3578 3579 3583 3587 3592 3597 3638 3641 3663 3666
    3667 3825 3835 3919 3949 3994 4004 4036 4061 4232 70-4117 70-4126 70-4133
    70-4139 70-4141 70-4185 70-4218 70-4219 70-4279 70-4282 70-4285 70-4308;
b) Serial numbers 3739 3753 3761 3764 3769 3776 3783 3791 3793 3796 3799 3801
    3802 3808 3827 3841 3846 3848 3858 3865 3877 3901 3945 3948 3953 3954 3955
    3957 3964 3965 3975 3981 3983 3989 3998 4002 4005 4008 4009 4011 4015 4017
    4019 4022 4027 4035 4053 4065 4067 4068 4072 4074 4084 4091 4096 5004 70-4097
    70-4107 70-4119 70-4122 70-4123 70-4124 70-4127 70-4129 70-4132 70-4135
    70-4136 70-4137 70-4142 70-4144 70-4145 70-4147 70-4149 70-4153 70-4154
    70-4157 70-4158 70-4159 70-4161 70-4166 70-4171 70-4172 70-4174 70-4175
    70-4176 70-4177 70-4183 70-4209 70-4215 70-4222 70-4224 70-4231 70-4241
    70-4244 70-4253 70-4258 70-4262 70-4272 70-4278 70-4288 70-4295 70-4299
    70-4301 70-4305 70-4306 70-4312 70-4317 70-4328 70-4329 70-4334 70-4335
    70-4343 70-4345 70-4346 70-4348 70-4349 70-4356;
c) Serial numbers: 3729 3345 3811 3845 3883 3973 3974 4021 4048 70-4083 70-4083
    70-4143 70-4152 70-4165 70-4167 70-4207 70-4235 70-4257 70-4281 70-4296
    70-4344;
d) Serial numbers: 3737 3738 3739 3758 3806 3817 3852 3856 3884 3891 3895 3896
   3904 3905 3912 3926 3929 3934 3937 3938 3944 3987 3988 4016 4049 4079 4082
    4095 70-4077 70-4113 70-4163 70-4168 70-4169 70-4184 70-4188 70-4197 70-4201
    70-4213 70-4217 70-4223 70-4283 70-4291 70-4297 70-4311 70-4314 70-4324
    70-4325;
e) Serial numbers: 3736 3756 3491 3849 3885 4087 70-4249 70-4286 70-4323
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated December 6, 2006. Firm initiated recall is ongoing.
REASON
Products collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
VOLUME OF PRODUCT IN COMMERCE
257 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L,
    45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430, Recall # Z-0385-2008;
2) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L,
    45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431,
    Recall # Z-0386-2008;
3) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L,
    45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432;
    Recall # Z-0387-2008;
4) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L,
    45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433,
    Recall # Z-0388-2008;
5) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L,
    47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440,
    Recall # Z-0389-2008;
6) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L,
    47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441,
    Recall # Z-0390-2008;
7) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L,
    47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442,
     Recall # Z-0391-2008;
8) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm
    A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451, Recall # Z-0392-
    2008;
9) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L,
    51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452,
    Recall # Z-0393-2008;
10) Depuy P.F.C. ® E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L,
      51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453,
      Recall # Z-0394-2008;
11) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59
       mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471,
      Recall # Z-0395-2008;
12) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L,
       45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521,
       Recall # Z-0396-2008;
13) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L,
      45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522,
      Recall # Z-0397-2008;
14) Depuy P.F.C. ® E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert,
      2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product
      Code/REF 96-0523, Recall # Z-0398-2008;
15) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L,
      45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527,
      Recall # Z-0399-2008;
16) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm
      A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544, Recall # Z-0400-
      2008;
17) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm
      A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551, Recall # Z-0401-
      2008;
18) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 2.5,
      8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630,
      Recall # Z-0402-2008;
19) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 8
      mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640,
      Recall # Z-0403-2008;
20) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3,
      10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641,
      Recall # Z-0404-2008;
21) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4,
      8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650,
      Recall # Z-0405-2008;
22) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component,
      4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651,
      Recall # Z-0406-2008;
23) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component,
      5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF
      96-0663, Recall # Z-0407-2008;
24) Depuy P.F.C. ® E RP Knee System Rotating Platform Curved Tibial Insert (RP-
      CVD), 10mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2041,
      Recall # Z-0408-2008;
25) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-
      STAB), 12.5mm, Size 2.5, UHMWPE, sterile; Product Code/REF 96-2122,
      Recall # Z-0409-2008;
26) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-
      STAB), 10 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2131,
      Recall # Z-0410-2008;
27) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132,
      Recall # Z-0411-2008;
28) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 15 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2133,
      Recall # Z-0412-2008;
29) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 17.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2134,
      Recall # Z-0413-2008;
30) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 10 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2141,
      Recall # Z-0414-2008;
31) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 12.5 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2142,
      Recall # Z-0415-2008;
32) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 10 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2161,
      Recall # Z-0416-2008;
33) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert
      (RP-STAB), 17.5 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2164,
      Recall # Z-0417-2008;
34) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L,
      47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643,
      Recall # Z-0418-2008;
35) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L,
      51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650,
      Recall # Z-0419-2008;
36) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L,
      51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652,
      Recall # Z-0420-2008;
37) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),
      64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712,
      Recall # Z-0421-2008;
38) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm
      M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713,
      Recall # Z-0422-2008;
39) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),
      71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF
      96-2730, Recall # Z-0423-2008;
40) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),
      71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF
      96-2731, Recall # Z-0424-2008;
41) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),
      71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF
      96-2732, Recall # Z-0425-2008;
42) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),
      71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF
      96-2733, Recall # Z-0426-2008;
43) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),
      71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF
      96-2736, Recall # Z-0427-2008;
44) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile;
      Product Code/REF 1498-11-310, Recall # Z-0428-2008;
45) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile;
      Product Code/REF 1498-11-410, Recall # Z-0429-2008;
46) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile;
      Product Code/REF 1498-12-206, Recall # Z-0430-2008;
47) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile;
      Product Code/REF 1498-12-208, Recall # Z-0431-2008;
48) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile;
      Product code/REF 1498-12-406, Recall # Z-0432-2008;
49) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile;
      Product code/REF 1498-12-506, Recall # Z-0433-2008;
CODE
1) Lot 79691A;
2) Lots 77219A, 77311A, 80904A, 81029A and 81189A;
3) Lots 77217A, 77218A, 79709A and 81043A;
4) Lots 77216A and 81807A;
5) Lots 81357A and 81354A.
6) Lots 80303A, 80304A, 80318A, 80319A, 80320A, 81323A, 81336A, 81342A,
      81343A, 81344A, 81346A, 81460A and 81470A;
7) Lots 78272A, 81303A and 81321A;
8) Lots 80370A and 80373A;
9) Lot 80347A;
10) Lots 80340A and 80341A;
11) Lot 81226A;
12) Lot 78904A;
13) Lot 79277A;
14) Lot 79273A;
15) Lot 79272A;
16) Lot 80278A;
17) Lot 79657A;
18) Lot 79927A;
19) Lots 77471A, 81083A and 81271A;
20) Lot 81160A;
21) Lot 81248A;
22) Lot 81254A;
23) Lot 80981A;
24) Lots 81170A and 81197A;
25) Lot 77454A;
26) Lots 79530A, 79646A, 79873A, 79874A, 79932A, 80690A, 80714A, 80931A and
      80940A;
27) Lots 79635A, 79856A, 79861A, 79865A, 80656A, 80661A and 80655A;
28) Lots 80745A, 80746A and 80763A;
29) Lot 80737A;
30) Lots 79597A, 79795A, 80832A and 80874A;
31) Lots 80911A and 80818A;
32) Lot 77436A;
33) Lot 77465A;
34) Lot 81084A;
35) Lot 81257A;
36) Lot 81268A;
37) Lot 79067A;
38) Lot 79066A;
39) Lot 79065A;
40) Lot 79064A;
41) Lot 79063A.
42) Lot 79062A;
43) Lot 80141A;
44) Lots XK6D84, XK6D94, XK6EA4, XK6EB4 and XK6EC4;
45) Lot W75BT4;
46) Lot W77B74;
47) Lot XB7C14;
48) Lot XJ1CV4;
49) Lots W85DF4, W85DG4, W85DJ4, W85DL4 and W85DM4
RECALLING FIRM/MANUFACTURER
Depuy Orthopedics, Inc., Warsaw, IN, by letters dated September 27, 2007. Firm initiated recall is ongoing.
REASON
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
VOLUME OF PRODUCT IN COMMERCE
1,158 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Boston Scientific Target, Transend EX Soft Tip Guide Wire .014 in /205cm, UPN: M001468060, Catalog Number: 46-806, Recall # Z-0122-2008
CODE
Lot Number: 9264947
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Miami, FL, by letter on June 14, 2007. Firm initiated recall is ongoing.
REASON
Mislabeling. Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Recall # Z-0279-2008
CODE
Lot Number: 48951
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter on October 12, 2007.
Manufacturer: TFX Engineering Ltd., Teleflex Medical, Limerick, Ireland. Firm initiated recall is ongoing.
REASON
Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.
VOLUME OF PRODUCT IN COMMERCE
14 boxes (70 units); 6 boxes (30 units)
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR DECEMBER 12, 2007

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