| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2320-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Cesarean section kit - Product Code OHM
|
| Product |
CESAREAN PACK - -
(7) TOWELS ABSORBENT 15" X 20"
(2) SCALPEL WEIGHTED SAFETY #1 0
(1) BLANKET BABY 30" X 30" POLY ABS IMP
(1) BOWL UTILITY QUART 32oz.
(1) TUBE FEEDING 8Fr. 15" LONG
(2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR
(1) BEANNIES BABY
(2) PAD OBSTRETICAL XLGE ST.
(1) SYRINGE 20cc W/0 NEEDLE LIL
(1) SYRINGE EAR/ULCER 2oz.
(1) BLANKET RECEIVING 100% COTION
(1) CLAMP UMBILICAL CORD ST.
(1) COVER TABLE REINFORCED 50" X 90"
(1) SYRINGE 10CC W/0 NEEDLE L/LOCK
(1) BOWL PLASTIC W/LID 80oz
(2) GOWN XL SMS IMPERVIOUS REINFORCED
(1) SHEET DRAPE 41" X 58" SMS
(1) DRAPE C SECTION W/POUCH 102" X 121" X 78"
(1) YANKAUER SUCTION TUBE W/0 VENT
(1) WRAPPER 30" X 30"
(15) SPONGE LAP PREWASH 18" X 18" XRD
(1) TIME OUT BEACON NON WOVEN ST.
(1) TUBE SUCTION CO NN ECT~" X 12'
(2) LIGHT SHIELD
(1) GOWN SURG REINF LARGE T/WRAP
(2) PK. STRIP STERI CLOSURE W' X 4"
(1) POLISHER CAUTERY TIP
(1) DRESSING COMP OP 4" X 14"
(1) COVER MAYO STAND REINFORCED
(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents |
| Code Information |
Product code 900-403, 30 lots: 112020525 112030955 112031372 112051682 112062486 112093590 112104107 112125170 112125315 113015449 113015695 113025960 113036485 113046957 113057479 113057817 113068169 113078573 113088813 113099289 113099571 131110076 131110409 131110586 131210970 140211667 140311937 140312382 140412836 140513246 |
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 |
30 lots; 4396 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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