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Terminated

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

FDA Recall Z-0566-2022 · Posted None

Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2021-12-22
Date Terminated2023-08-15
Product Quantity692 units

Reason for Recall

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

Firm Action

All USA Distributors and healthcare facilities that were directly shipped impacted devices were sent a Product Advisory Notice beginning on December 22, 2021 by email. Clinical Consignees were instructed to evaluate their facilities inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and return impacted product. The clinician may recognize that the External Retention Bolster is too large for the accompanying PEG tube when initially use the product. Consignees were instructed to complete an Acknowledgement Form and return a copy of the form to Avanos within five (5) days.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924065MIC PEG TUBEMedical Innovations Corp. · 1994-02-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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