PlainRecalls
FDA Devices Critical Class I Ongoing

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 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product

Reported: March 13, 2024 Initiated: January 16, 2024 #Z-1187-2024

Product Description

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 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;

Reason for Recall

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Details

Recalling Firm
Avanos Medical, Inc.
Units Affected
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: Canada, Colombia, Costa Rica, UAB, Israel, Kuwait, and Panama.
Location
Alpharetta, GA

Frequently Asked Questions

What product was recalled?
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 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;. Recalled by Avanos Medical, Inc.. Units affected: 53126 Units.
Why was this product recalled?
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 13, 2024. Severity: Critical. Recall number: Z-1187-2024.