FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
- Recall number
- Z-0566-2022
- Recalling firm
- Avanos Medical, Inc.
- Product
- MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
- Status
- Terminated
- Initiated
- 2021-12-22
- Posted
- not on file
- Terminated
- 2023-08-15
- Reason
- The External Retention Bolster contained in the kit may be a larger diameter than the tube.
- Root cause
- Under Investigation by 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.
- Quantity
- 692 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Chile.
- Lot, serial or model codes
- 1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544
- 510(k) numbers
- ["K924065"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28