Recall Z-1322-2009 ยท MCZ Suture Removal Kit
Tri-State Hospital Supply Corporation
Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT3390.
| Date | Apr 30, 2009 (initiated Jan 14, 2009) |
| Status | Terminated |
| Reason | Compromised sterility, as the package seals may be inadequate. |
| Root cause | Packaging process control |
| Action | A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135. |
| Quantity | 112 |
| Distribution | Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.