Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: Name and Version (if applicable)
- Product List: Avanos Affected Devices Due to Nurse Assist, LLC Pre-Filled Syringe Recall
- Distribution Dates: January 31, 2022 to December 7, 2023
- Devices Recalled in the U.S.: 61,427
- Date Initiated by Firm: January 16, 2024
Device Use
Avanos Medical MIC Gastric-Jejunal Feeding Tube and MIC Gastric-Jejunal Feeding Tube with ENFit Connectors are designed for patients who require simultaneous gastric decompression and jejunal feeding.
Reason for Recall
Avanos Medical, Inc., is recalling certain lots of MIC Gastric-Jejunal Feeding Tube - Endoscopic/Radiologic Placement kit and MIC Gastric-Jejunal Feeding Tube with ENFit Connectors - Endoscopic/Radiologic Placement kits in direct response to Nurse Assist recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns. These kits include the recalled Nurse Assist supplied syringes, pre-filled with sterile water.
Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the Avanos feeding tube kit affected by the Nurse Assist recall.
There have been no complaints, injuries, or deaths associated with this issue.
Who May be Affected
- Health care providers using MIC Gastric-Jejunal Feeding Tube - Endoscopic/Radiologic Placement kit and MIC Gastric-Jejunal Feeding Tube with ENFit Connectors - Endoscopic/Radiologic Placement kit.
- People who receive care using MIC Gastric-Jejunal Feeding Tube - Endoscopic/Radiologic Placement kit and MIC Gastric-Jejunal Feeding Tube with ENFit Connectors - Endoscopic/Radiologic Placement kit.
What to Do
On January 16, 2024, Avanos Medical, Inc. sent all affected customers an Urgent Medical Device Recall.
This letter requested customers to:
- Continue to perform normal post op care for any newly placed MIC GJ tube.
- Follow the Daily Care & Maintenance Check List found in the product Instructions for Use:
- Assess the patient for any signs of pain, pressure or discomfort.
- Assess the stoma site for any signs of infection, such as redness, irritation, edema, swelling, tenderness, warmth, rashes, purulent, or gastrointestinal drainage.
- Assess the patient for any signs of pressure necrosis, skin breakdown, or hypergranulation tissue.
- Report any adverse events involving these products immediately to PIQ@avanos.com.
- Check all storage facilities and warehouse locations for affected products and quarantine them.
- Complete the Customer Response Form which can be found online, or by using the QR code provided in the notice accompanying the letter.
- Destroy all affected lots in your inventory per your facility’s procedures. Alternatively, if you are unable to destroy your affected inventory, please indicate so on the form and you will be provided information on how to return product for destruction.
- Identify all distribution partners and notify them of the product recall with a copy of the notification letter.
Contact Information
Customers in the U.S. with questions about this recall should contact Avanos by emailing avanos-fca-2024-001@iqvia.com or calling 1-855-201-1355.
Additional Resources:
- Medical Device Recall Database Entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.