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U.S. Department of Health and Human Services

Class 1 Device Recall Customed

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  Class 1 Device Recall Customed see related information
Date Initiated by Firm May 20, 2014
Date Posted August 29, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-2437-2014
Recall Event ID 68536
Product Classification General surgery tray (kit) - Product Code LRO
Product LITHOTOMY PACK
CONTENTS:
(2) TOWELS ABSORBENT 15" X 20"
(2) LEGGINGS W/7'' CUFF 30" X 42" CSR
(1) DRAPE UNDERBUTTOCK WITH POUCH 44" x 35"
(1) DRAPE ABDOMINAL WITH TAPE 40" X 54"
(1) DRAPE UTILITY WITH TAPE
(1) TABLE COVER REINFORCED 50" X 90"
(1) TIME OUT BEACON NON WOVEN ST.


Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-2167, 29 lots 111041037 111051291 111061531 111102864 112010130 112020462 112030812 112041223 112051942 112062480 112072798 112083163 112083421 112093927 113057460 113067915 113078469 113088789 113089024 113109643 113109789 131110238 131210786 140111203 140312119 140412646 140513126 140513397 140613659 
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 29 lots/2675 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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