| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2342-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Obstetrical kit - Product Code OKV
|
| Product |
0.B. PACK - -
(1) TABLE COVER 44" x 90"
(1) UNDERBUTTOCK DRAPE WITH POUCH
(2) LEGGINS WITH 7" CUFF 30" x 42"
(1) GOWN IMPERVIOUS REINFORCED LARGE SMS
(3) TOWELS ABSORBENT 15" x 20"
(1) PAD OBSTETRICAL X-LARGE
(1) VAGINAL SPONGE XRD
(10) GAUZE SPONGES 4" X 4" 12PLY XRD
(1) CORD UMBILICAL CLAMP
(1) BABY BLANKET PRINTED
(2) EAR/ULCER SYRINGE 2oz
(1) SET UP COVER CLEAR POLY
(1) BASIN WASH 7QT.
(1) ABDOMINAL DRAPE WITH TAPE LIF
(2) KELLY FORCEP STRAIGHT 5 %
(1) MAYO SCISSOR STRAIGHT 6%
(1) BABY BEANNIES
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Code Information |
Product code 900-645, 51 lots: 109030612 109030699 109051050 109051212 110061464 110071705 110081981 110082075 110092405 110112816 110122898 111010147 111020295 111030648 111041071 111051300 111061559 111071831 111092556 111102774 111112951 111112964 111123280 112010194 112010255 112030736 112052003 112083214 112093731 112104256 112114396 112125106 112125305 113015456 113025965 113036376 113047028 113057498 113078339 113078575 113099294 113099575 131110079 131110411 131110588 140111243 140211676 140211878 140412472 140412889 140513351 |
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 |
51 lots; 5574 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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