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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-2408-2014
Recall Event ID 68536
Product Classification Cesarean section kit - Product Code OHM
Product CESAREAN PACK -
(1) MAYO STAND COVER REINFORCED LIF
(5) TOWELS ABSORBENT LIF
(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F
(3) DRAPE SHEET 41" X 58" SMS LIF
(1) BABY BLANKET PRINTED LIF
(1) BOWL PLASTIC 80oz WITH LID
(1) TUBE SUCTION CONNECT.%" X 12' LIF
(15) LAP SPONGES PREWASH XRD LIF
(1) EAR ULCER SYRINGE 2oz. LIF
(1) PAD OBSTETRICAL X-LARGE ST. L/F
(1) YANKAUER SUCTION TUBE WITHOUT VENT L/F
(1) SYRINGE 20cc SITIP LIF
(1) FEEDING TUBE 8FR. 15" LONG
(1) BABY BEANNIES LIF
(1) DRESSING ISLAND 4" X 14"
(1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78"
(1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP
(1) TABLE COVER REINFORCED 50" X 90" L/F
(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF
(1) SUTURE BAG FLORAL LIF
(1) UMBILICAL CORD CLAMP
(1) BLADE SURGICAL #20 CARBON STEEL
(1) WRAPPER 24" X 24" L/F

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1719, 23 lots: 111082259 111092364 111123379 112010086 112020404 112041199 112051873 112062447 112125292 113015635 113026050 113036756 113057398 113067894 113078273 113088759 113099390 113109748 131210760 140111171 140211792 140312084 140412458 
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 23 lots; 804 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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