Recall Z-1068-2019 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Medical Action Industries Inc
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12
| Date | Mar 1, 2019 |
| Status | Terminated |
| Reason | Potential lack of sterility assurance |
| Root cause | Under Investigation by firm |
| Action | Medical Action Industries notified customers on about 03/01/2019, via "URGENT: MEDICAL DEVICE NOTIFICATION OF RECALL." Instructions for end-users included to examine inventory for affected product, remove any affected product and immediately place it in quarantine, complete and return the provided Recall Response Form, and arrange for the return of all affected product on hand. Instructions for distributors included to examine inventory for affected product, remove any affected product and immediately place it in quarantine, notify any customers if affected product was further distributed, |
| Quantity | 228,300 packs (5 units/pack) |
| Distribution | Distributed nationwide to AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WY. Also distributed to Canada and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.