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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-2321-2014
Recall Event ID 68536
Product Classification Ring, laparotomy - Product Code PHI
Product MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD
(1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz
(1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER
(1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE
(2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED
(4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS
(2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED
(1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN
(5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER 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 900-404, 35 lots: 102030840 111030924 111041044 111051296 111061668 111123243 112010164 112020524 112041317 112041373 112041448 112062487 112083429 112114599 112125087 112125314 113025961 113036355 113036763 113047220 113057480 113057846 113068046 113078323 113078574 113089071 113099290 113099572 131110410 131110587 131210971 140111452 140211742 140412837 140513247 
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 35 lots; 11472 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.
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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