| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2505-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product |
SHOULDER PACK
CODE 900-2766
CONTENTS:
(1) STAPLE SKIN 35 WIDE LIF
(1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21"
(1) TABLE COVER 44" X 90"
(4) TOWELS ABSORBENT 15" X 20" LIF
(2) TUBE SUCTION CONNECT" X 12' LIF
(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL
(1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11
(1) NEEDLE SPINAL ANESTH 18G X 3% LIF
(1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF
(2) ATTACHABLE POUCH BEACH CHAIR 35" X 43" WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F
(4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17" X 11" LIF (1) BOWL UTILITY 32oz.
(1) STOCKINETTE 6" X 48" L/F
(5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 24" X 24"
(1) NEEDLE HYPODERMIC 22G X 1 %
(1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT
(1) MAYO STAND COVER REINFORCED LIF
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Code 900-2766, 6 lots 113078317 131110257 131210801 140111215 140312143 140412666 |
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 |
6 lots, 171 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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