MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
FDA Recall Z-0565-2022 · Posted None
Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2021-12-22
Date Terminated2023-08-15
Product Quantity2652 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.