MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
This recall has been terminated (originally issued December 22, 2021).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- December 22, 2021
- Terminated
- August 15, 2023
- Recall Number
- Z-0565-2022
- Quantity
- 2652 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Lot / Code Info
1) Code 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345
Root Cause
Under Investigation by firm
Action Taken
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.