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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-2331-2014
Recall Event ID 68536
Product Classification Ring, laparotomy - Product Code OKV
Product PERY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78" UF
(2) TOWEL ABSORBENT 15" X 20" LIF
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED
(1) DRAPE UNDERBUTTOCK WITH POUCH
(1) UTILITY BOWL 16oz.
(10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF
(1) ROBNEL CATHETER 18FR.
(1) DRAPE SHEET 41 " X 58" SMS
(2) LEGGINS WITH 7" CUFF 30" X 42"
(1) DRAPE UTILITY WITH TAPE UF

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Code Information Product code 900-548, 60 lots: 109010181 109030603 109051042 109061206 109071558 109081861 109092069 109102334 109112579 109122695 110010096 110020395 110030677 110040948 110051248 110051360 110061461 110071847 110082073 110092262 110092399 110112663 110123108 111010139 111020289 111030691 111040905 111051209 111061555 111071826 111082102 111092553 111102766 111123268 112010186 112020489 112030845 112041337 112051995 112062490 112072805 112083434 112093640 112104099 112114678 113015454 113036442 113047025 113047205 113057493 113057747 113068175 113088875 113099441 113109856 131110266 131210828 140111238 140211731 140211940 
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 60 lots; 4896 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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