Recall Z-2466-2014 ยท FDE Laparoscopy Kit
Customed, Inc
LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAPE LAPAROSCOPY CHOLE W/TROU (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs package
| Date | Aug 29, 2014 (initiated May 20, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Coor |
| Quantity | 5 lots/1269 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.