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U.S. Department of Health and Human Services

Class 2 Device Recall MIC Percutaneous Endoscopic Gastrostomy PEG Kit

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  Class 2 Device Recall MIC Percutaneous Endoscopic Gastrostomy PEG Kit see related information
Date Initiated by Firm December 22, 2021
Create Date February 07, 2022
Recall Status1 Terminated 3 on August 15, 2023
Recall Number Z-0565-2022
Recall Event ID 89290
510(K)Number K924065  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Code Information 1) Code 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Lisa Clark
470-448-5544
Manufacturer Reason
for Recall		 The External Retention Bolster contained in the kit may be a larger diameter than the tube.
FDA Determined
Cause 2		 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 in Commerce 2652 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNT and Original Applicant = MEDICAL INNOVATIONS CORP.
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