| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2343-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Cesarean section kit - Product Code OHM
|
| Product |
CESAREAN PACK- -
(3) ABSORBENT TOWELS 15" x 20" LIF
(1) PLASTIC BOWL WITH LID 80oz.
(1 0) LAP SPONGES PRE-WASH 18" x 18" XRD
(2) PAD OBSTETRICAL X-LARGE ST.
(1) MAYO STAND COVER REINFORCED LIF
(1) DRAPE SHEET 41" x 58" SMS LIF
(2) TUBE SUCTION CONNECT. Y.." X 12' LIF
(1) EAR ULCER SYRINGE 2oz. LIF
(1) YANKAUER SUCTION TUBE WITHOUT VENT L/F
(1) UMBILICAL CORD CLAMP
(1) SURGICAL BLADE #20 CARBON STEEL
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF
(1) DRESSING ISLAND 4" X 1 0"
(1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78"
(1) BABY BLANKET PRINTED
(1) GOWN IMPERVIOUS REINFORCED LARGE SMS
(1) BAG SUTURE FLORAL
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-660, 47 lots: 110061532 110071635 110071853 110102449 110112671 110122899 111010148 111020375 111030650 111040914 111051212 111061560 111071832 111082224 111092400 111102775 111112949 111123281 112010195 112020516 112030737 112041345 112052004 112062504 112083440 112093591 112093732 112114595 112125107 113015698 113025966 113036597 113036730 113057500 113057875 113068179 113088883 113099295 113109867 131110270 131110412 131110589 131210972 140111453 140211677 140211945 140513352 |
Recalling Firm/
Manufacturer |
Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
|
| For Additional Information Contact |
Rosemari Melendez
787-622-5151 Ext. 7540
|
Manufacturer Reason
for Recall |
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
|
FDA Determined
Cause 2 |
Package design/selection |
| Action |
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540 |
| Quantity in Commerce |
47 lots; 5560 units (multiple units per lot) |
| Distribution |
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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