MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -

FDA device recall Z-1187-2024 · posted 2024-03-01 · Open, Classified

Recall details

Recalling firm

Avanos Medical, Inc.

Reason for recall

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

Action taken

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 gastrointestinal drainage. o 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: https://iqvia-response.my.site.com/mt/fca?cid=avanos-fca-2024-001, or by using the QR code provided in the Field Correction Acknowledgement Instructions accompanying this letter. " Destroy all affected lots in your inventory per your facility s procedures o 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. o A refund will be provided to you based on the quantity of affected product you have indicated on the Customer Response Form. " Distributors only: alert your affected customers of this recall. We ask that you work with them to destroy affected product and provide them refunds as per your internal processes. Provide to Avanos an updated response using the Customer Response Form to receive refunds or credit for your customers affected products. " Please reach out to avanos-fca-2024-001@iqvia.com or call (855) 201-1355 with any questions or concerns regarding these instructions.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KNT

Quantity 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

Date initiated

2024-01-16

Date posted

2024-03-01

Location

Alpharetta, GA

Related 510(k) clearances