The Recall Desk
SevereFDA (Devices)·Z-1187-2024·Announced 2024-03-13

Avanos Medical recalls MIC gastric-jejunal feeding tubes with defective syringe

Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits containing a sterile pre-filled syringe that was recalled by Nurse Assist. Approximately 53,126 units were distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4. The feeding tubes contain a recalled syringe component. No deaths or serious injuries are reported in the source text.

Plain-English summary

Avanos Medical, Inc. is recalling MIC Gastric-Jejunal Feeding Tube Kits due to a defective component. The kits contain a sterile pre-filled syringe that was subsequently recalled by Nurse Assist, Inc.

The affected products include multiple sizes (16 French, 18 French, and 22 French) available for endoscopic/radiologic or surgical placement. Approximately 53,126 units have been distributed worldwide, including throughout the United States, Puerto Rico, and to Canada, Colombia, Costa Rica, United Arab Emirates, Israel, Kuwait, and Panama.

Patients and healthcare providers should consult with their healthcare provider regarding these affected feeding tubes. Detailed product codes, batch numbers, and UDI/DI codes are available on the FDA website for identifying affected units.

The recalled product

Product
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 Co
Manufacturer
Avanos Medical, Inc.
Hazard
  • component-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) Product Code 0250-16
  • UDI/DI 00350770954806
  • Batch Numbers: 30180718
  • 30181870
  • 30184758
  • 30186768
  • 30194327
  • 30226669
  • 30226817
  • 30229831
  • 30240299
  • 30244886
  • 30248036
  • 30248348
  • 30251106
  • 30251988
  • 30254746
  • 30258134
  • 30267592
  • b) Product Code 0250-16-15

Distribution

Distributed nationwide across the United States.