Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2411-2014 |
Recall Event ID |
68536 |
Product Classification |
General surgery tray (kit) - Product Code LRO
|
Product | UROLOGY PACK -
(3) TOWELS ABSORBENT 15" X 20" UF
(1) WASH BASIN ROUND 6QT.
(1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN
(1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX
(1) BAG SUTURE FLORAL
(1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP
(1) TABLE COVER 44" X 90" UF
(2) DRAPE SHEET 42" X 55" SMS UF
(1) TUBE SUCTION CONNECT. Y." X 12' UF
(1) MAYO STAND COVER REINFORCED UF
(10) GAUZE SPONGE 4" X 4" 16PLY
(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED
(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL
(1) TUR Y SET TWO LEAD ST. UF
(1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
Code Information |
Product code 900-1742, 14 lots: 111113032 111123382 112010089 112020407 112041202 112051876 112083407 112093915 112125157 113015435 113036757 140412562 140513111 140513393 |
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 | 14 lots; 325 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 |
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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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