Date Initiated by Firm | May 20, 2014 |
Date Posted | August 29, 2014 |
Recall Status1 |
Terminated 3 on August 14, 2017 |
Recall Number | Z-2330-2014 |
Recall Event ID |
68536 |
Product Classification |
laparoscopy kit - Product Code FHI
|
Product | LAPAROTOMY BASIC PACK- CUSTOMED-
(1) TABLE COVER REINFORCED 44" X 78" LIF
(1) COVER MAYO STAND REINFORCED UF
(2) TOWEL ABSORBENT 15" X 20" UF
(1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y
(2) DRAPE SHEET 41 " X 58" SMS UF
(4) DRAPE UTILITY WITH TAPE L/F
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents |
Code Information |
Product code 900-547, 19 lots: 109010180 109030602 110020394 110041044 110061584 110071846 110112813 111030690 111102881 112020520 112030884 112051719 112083433 113025793 113036491 113046966 113057746 140111076 140312175 |
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 | 19 lots; 550 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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