Recall Z-1935-2018 ยท GAB Needle, Suturing, Disposable
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
| Date | Apr 24, 2018 |
| Status | Terminated |
| Reason | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters. |
| Root cause | Package design/selection |
| Action | Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704. |
| Quantity | 23150 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.