Z-1557-2021Class I

Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

Name: Z-1557-2021 Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Creator: Medical Action Industries, Inc. 306
Published: 2021-04-09
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2021-04-09 / Terminated / root cause: packaging

FDA source

Medical Action Industries, Inc. 306 began a recall of Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B on 2021-04-09. FDA classified it as Class I and gives the reason as "Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1557-2021
Classification: Class I
Status: Terminated
Initiated: 2021-04-09
Posted: 2021-05-12
Terminated: 2023-10-03
Recalling firm: Medical Action Industries, Inc. 306
Product: Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Product code: PEZ Central Venous Catheter Dressing Change Kit
Reason for recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: A written notification letter titled, "URGENT: RECALL NOTIFICATION" was sent to all consignees on 04/09/2021 via email. The letter sent to the distributors instructs the consignees to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignees are instructed to discard any inventory they may have on hand in accordance with the distributor's facility s standard procedures. If any of the affected products identified above were further distributed, the distributor is to ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. An example of an end-user letter that the distributor can use to notify their customers is attached. The distributor is asked to please report number of responses received and quantities destroyed to [email protected]. The consignee is asked to complete the Recall Response Form and return it as soon as possible even if they do not have product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Material Authorization form when the recalled product is destroyed and return to [email protected] to receive credit. The letter also mentions that any adverse events associated with the use of the affected kits should be reported to [email protected]. The letter that was sent to the end users instructs the consignee to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignee is to discard any inventory they may have on hand in accordance with their facility' s standard procedures. The consignee is to complete the Recall Response Form and return it as soon as possible even if the consignee has no current product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Ma
Quantity in commerce: 10 cases (20 kits per case)
Distribution: Distributed US nationwide to OH, OR, FL and CA.
Product codes and lots: Kit Number: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1557-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1554-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12
Z-1555-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12
Z-1556-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12
Z-1557-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12
Z-1558-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12
Z-1559-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12

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)