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U.S. Department of Health and Human Services

Class 2 Device Recall Central Line Dressing Change Kit

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  Class 2 Device Recall Central Line Dressing Change Kit see related information
Date Initiated by Firm September 08, 2021
Create Date October 19, 2021
Recall Status1 Terminated 3 on October 13, 2023
Recall Number Z-0147-2022
Recall Event ID 88687
Product Classification Central venous catheter dressing change kit - Product Code PEZ
Product Kit: Central Line Dres Change 20/Cs
Code Information Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024  UDI: 20809160170523
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer Reason
for Recall		 The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
FDA Determined
Cause 2		 Process control
Action A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.
Quantity in Commerce 42 cases
Distribution Distribution to a single US distributor in Michigan
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.
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