Moderate riskFDA DeviceClass II

Avanos MIC Safety PEG Kit recalled for defective lidocaine injection component

Avanos Medical included lidocaine hydrochloride injection from a recalled supplier in sterile feeding tube kits. The supplier had recalled the lidocaine due to quality issues. Approximately 53 kits with lot number 30370718 were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have the MIC Safety PEG Kit model 8170-14 (14 Fr) with lot number 30370718.
  2. Do not use the kit if you have it.
  3. Contact your healthcare provider or Avanos Medical for instructions on safe use or replacement.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 20 products — see all of them.

Details

Units affected
53 kits
Illnesses reported
None reported
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Classification
Class II
Recall number
Z-2347-2026

In the FDA's words

Description
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007813, Lot Number 30370718 Distribution: US Nationwide distribution. Affected quantity: 53 kits
Hazard
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

20 products in this recall

Avanos CORFLO, MIC PEG kits recalled for lidocaine quality issue

Avanos Medical is recalling 20 PEG feeding tube kits sold under the CORFLO and MIC Safety names. The kits were made with lidocaine hydrochloride injection that is itself subject to a supplier recall for quality issues. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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