| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2365-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Obstetrical kit - Product Code OKV
|
| Product |
PERl GYN PACK
(1) TABLE COVER 44" x 90"
(2) LEGGINS W/7" CUFF 30" x 42"
(1) ABDOMINAL DRAPE WITH TAPE LIF
(2) TOWELS ABSORBENT 15" X 20"
(10) GAUZE SPONGE 4" X 4" 16PLY
(2) DRESSING NON ADH TELFA 4" X 3"
(1) ROBINSON RED CATHETER 14FR.
(1) UNDERBUTTOCK DRAPE WITH POUCH
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-997, 54 lots: 109010132 109020292 109061223 109061459 109081892 109092100 109102355 109112608 109122830 110010122 110030692 110030798 110061476 110071720 110081986 110092293 110092410 110112818 111010176 111020308 111030676 111041119 111051306 111061572 111071842 111082121 111082231 111092411 111102790 111113148 111123310 112020497 112030758 112041366 112052028 112072881 112083445 112093959 112104309 112125125 113015522 113025975 113026120 113036394 113057518 113078481 113088901 113099461 113109885 140111263 140211865 140312193 140412708 140513386 |
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 |
54 lots; 2965 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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