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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-2407-2014
Recall Event ID 68536
Product Classification Gynecological laparoscopic kit - Product Code OHD
Product O.B. PACK -
(I) TABLE COVER REINFORCED 50" X 90" LIF
(I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35"
(2) LEGGINS W/7'' CUFF 30" X 42"
(1) GOWN LARGE SMS IMPERVIOUS REINFORCED
(3) TOWELS ABSORBENT 15" X 20" LIF
(I) PAD OBSTETRICAL X-LARGE ST.
(I) PACKING VAG JNAL 4" X 36" 8PL Y XRD
(10) GAUZE SPONGES 4" X 4" 12PLY XRD
(I) UMBILICAL CORD CLAMP
(1) BABY BLANKET PRINTED
(2) EAR/ULCER SYRINGE 2oz. LIF
(I) COVER SET UP 42" X 75" CLEARPOLY
(1) DRAPE ABDOMINAL WITH TAPE L/F
(1) BOWL WITH LID PLASTICS 80oz. L/F
(1) SHEET DRAPE 41" X 58" SMS LIF

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1717, 49 lots: 109102292 109112479 109122763 110030824 110040903 110061439 110071672 110081970 110082178 110092389 110112617 110122925 111010065 111020275 111030600 111051279 111061510 111071778 111082063 111092363 111102698 111113030 111123378 112010085 112020403 112030641 112041198 112051872 112062446 112072784 112083404 112093911 112104294 112114647 112125031 113036755 113057397 113067893 113078272 113088758 113089199 113099389 131110197 131210759 140111170 140312083 140412457 140513109 140613626 
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 49 lots; 1804 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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