Recall Z-1955-2014 ยท OVN Suture Kit
Medical Action Industries Inc
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
| Date | Jul 1, 2014 (initiated Jun 12, 2014) |
| Status | Terminated |
| Reason | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014. |
| Quantity | 474 cs (9,480 ea) total for all kits involved |
| Distribution | Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.