| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2439-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product |
SHOULDER ARTHROSCOPY PACK
CONTENTS:
(1) SUTURE BAG FLORAL
(1) UTILITY BOWL 32oz.
(2) DRAPE SHEET 70" X 100"
(1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST.
(1) STOCKINETTE 6 X 48"
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11
(1) BULB SYRINGE 60cc
(1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY
(10) LAP SPONGE PREWASH 18" X 18" XRD
(2) U-DRAPE 60" X 70" WITH TAPE SPLIT
(2) DRAPE SHEET 41" X 58" SMS
(1) STOCKINETTE IMPERVIOUS 14" X 48"
(1) TABLE COVER REINFORCED 50" X 90"
(1) COBAN WRAP TAN 4" X 5yds
(1) TIME OUT BEACON NON WOVEN
(2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV
(2) MAYO STAND COVER REINFORCED
(1) SKIN MARKER INK WITH 8 LABEL
(1) TUBE CONNECTING SUCTION X" X 12'
(1) MAYO TRAY SMALL
( 1) CAMERA COVER W/ELAST.
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-2193, 28 lots 111082204 111092380 111113084 111123219 111123426 112041379 112083164 112093928 113015445 113026056 113036438 113036728 113046937 113057461 113067867 113078470 113078790 113099287 113109790 131110074 131110499 131210647 131210968 140111415 140311935 140312380 140412834 140513127 |
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 |
28 lots/1707 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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