Recall Z-0681-2019 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Medical Action Industries Inc
Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasi
| Date | Nov 27, 2018 |
| Status | Terminated |
| Reason | Potential compromise of product sterility due to breach of sterile barrier. |
| Root cause | Under Investigation by firm |
| Action | Medical Action Industries notified customers on about 11/27/2018 via "URGENT MEDICAL DEVICE NOTICE OF RECALL" Letter. Consignees were instructed to immediately examine inventory, quarantine all affected product, notify customers if the affected product was further distributed, and complete and return the recall response form. For consignees with affected product in inventory, Medical Action Industries will issue a Returned Materials Authorization (RMA) to return affected product. |
| Quantity | 13 cases (2,600 sponges) |
| Distribution | Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.