Z-0147-2022Class II

Kit: Central Line Dres Change 20/Cs

Name: Z-0147-2022 Kit: Central Line Dres Change 20/Cs
Creator: Medical Action Industries, Inc. 306
Published: 2021-09-08
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2021-09-08 / Terminated / root cause: manufacturing process

FDA source

Medical Action Industries, Inc. 306 began a recall of Kit: Central Line Dres Change 20/Cs on 2021-09-08. FDA classified it as Class II and gives the reason as "The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0147-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-08
Posted: 2021-10-19
Terminated: 2023-10-13
Recalling firm: Medical Action Industries, Inc. 306
Product: Kit: Central Line Dres Change 20/Cs
Product code: PEZ Central Venous Catheter Dressing Change Kit
Reason for recall: The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0147-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0147-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code PEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)