Z-0532-2025Class II

(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV...

Name: Z-0532-2025 (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-15 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile on 2024-10-15. FDA classified it as Class II and gives the reason as "Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0532-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-15
Posted: 2024-11-25
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: The recalling firm issued letters on and dated 10/15/2024 via email and first-class mail explaining the issue, potential risk, and informing the consignee stickers are to be provided upon request to be placed onto the Medline pack instructing that the affected component is to be removed and replaced with an item in inventory. Required actions were included which were to (1) Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately; (2) Use the link and information in the letter to complete the response form. List the quantity of affected product in inventory on the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the consignee staff to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight; (4) If the consignee is a distributor or has resold or transferred this product to another company or individual, the consignee is to notify them of the recall communication.
Quantity in commerce: 408 kits
Distribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Product codes and lots: (1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277; (2) REF DYNJ903016G - Lot numbers 24DBP801, exp. 8/31/2025; and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0533-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0534-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25

Product code OEZ

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)