Recall Z-0525-2019 ยท NAB Gauze / Sponge,Nonresorbable For External Use
ASO, LLC
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
| Date | Oct 16, 2018 |
| Status | Open, Classified |
| Reason | Potential that gauze pads may not be fully sterilized |
| Root cause | Under Investigation by firm |
| Action | ASO, LLC notified customers of the recall on about 10/16/2018 via "URGENT: MEDICAL DEVICE RECALL" letter sent to corporate. Instructions were to immediately stop using/distributing the affected gauze pads, place them in quarantine, and return to ASO LLC. Customers were also instructed to complete and return the response form. |
| Quantity | 218 cases (72, 10-ct boxes per case) |
| Distribution | Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.