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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-2385-2014
Recall Event ID 68536
Product Classification Obstetrical kit - Product Code OKV
Product PREMIUM O.B. PACK - CUSTOMED-
(1) TABLE COVER REINFORCED 50" X 90" LIF
(10) GAUZE SPONGES 4" X 4" 12PLY LIF
(2) LEGGINS WITH 7" CUFF 30" x 42" LIF
(2) PAD OBSTETRICAL X-LARGE ST.
(2) SHEET DRAPE 42" X 55" LIF
(1) UNDERBUTTOCK DRAPE WITH POUCH LIF
(1) DRAPE ABDOMINAL 40" X 54" WITH TAPE LIF
(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF
(1) BOWL PLASTIC 80oz WITH LID
(1) EAR ULCER SYRINGE 2oz LIF
(1) CORD UMBILICAL CLAMP LIF
(1) BABY BLANKET IMP. 30" X 30" POLY ABS. LIF
(1) TOWELS ABSORBENT 15" X 20" LIF
(1) LAP SPONGE PRE-WASH 18" X 18" XRD LIF

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1297, 44 lots: 109030542 110061517 110071663 110081957 110082065 110082132 110112605 110112866 110123051 110123066 111030563 111071760 111082184 111082268 111092487 111102647 111102672 111112928 111112962 111123334 112010034 112020327 112041184 112062405 112062406 112062582 112062620 112083387 112114633 112124935 113015426 113025935 113036315 113036450 113047324 113068144 113078692 113109719 131110167 131110596 131210959 140111406 140412596 140513080 
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 44 lots; 4670 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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