| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2341-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Obstetrical kit - Product Code OKV
|
| Product |
PERY GYN PACK-
(1) DRAPE UTILITY WITH TAPE UF
(1) UNDERBUTTOCK DRAPE WITH POUCH
(2) ABSORBENT TOWELS 15" x 20" UF
(2) LEGGINS W/7'' CUFF 30" X 42"
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) ABDOMINAL DRAPE WITH TAPE UF
(1) UTILITY BOWL 16oz.
(1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF
(1) PAD OBSTETRICAL XL LIF
(2) SPECIMEN CONTAINER 4oz. W/LID & LABEL
(1 ) SYRINGE 1 Occ PREFILLED W/GEL
(1 ) DRAPE SHEET 41 " X 69" MEDIUM UF
(1 ) CATHETER 14FR. ROB. NELAT
(1) NON-ADHESIVE TELFA DRESSING
(2) GOWN IMP. REINFORCED LGE SMS
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-635, 42 lots: 110040968 110051274 110051406 110092404 110112815 110112897 111020476 111030646 111041113 111051299 111061558 111071830 111082247 111092399 111102773 111112950 111123278 112020492 112041343 112083439 112093730 112125105 112125304 113015514 113036673 113036736 113047027 113057609 113067934 113068178 113088881 113099448 113109866 113507497 131110310 131210835 140111242 140211675 140211944 140312385 140412840 140513250 |
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 |
42 lots; 4790 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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