Recall Z-2296-2010 ยท GDI Dissector, Surgical, General & Plastic Surgery
He, Inc
V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.
| Date | Aug 27, 2010 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | Sterile product packaging contains weak seals, which may result in compromised product sterility. |
| Root cause | Packaging |
| Action | Harod Enterprises, Inc. (HE) issued a "Notice of Recall" letter to Cardinal Health/V. Mueller dated March 1, 2010 identifying the issue and affected product. Cardinal Health/V. Mueller will issue a subrecall letter to all their customers (end users) instructing them to discontinue use of the affected lots and return for replacement. and will track all responses and removal of the product from their private label customers. HE will repackage and/or replace all returned product. Consignees can contact Harod Enterprises, Inc. at 1-706-228-5165. |
| Quantity | 551 cases of 100 packages per case |
| Distribution | Nationwide: including state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.