Recall Z-1187-2024 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-2
| Date | Mar 1, 2024 (initiated Jan 16, 2024) |
| Status | Open, Classified |
| Reason | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. |
| Root cause | Nonconforming Material/Component |
| Action | AVANOS MEDICAL, INC. issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 01/16/2024 via FedEx. The notice explained the issue, the potential risk to health, and requested the following actions be taken: " Please continue to perform normal post op care for any newly placed MIC GJ tube. Per the Daily Care & Maintenance Check List found in the product Instructions for Use: o Assess the patient for any signs of pain, pressure or discomfort. o Assess the stoma site for any signs of infection, such as redness, irritation, edema, swelling, tenderness, warmth, rashes, purulent, or |
| Quantity | 53126 Units |
| Distribution | Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION Medical Innovations Corp., May 2, 1994 |