FDA Medical devices recall ·
(1) Medline Open Heart CDS recall
- Recall number
- Z-0532-2025
- Date
- (initiated October 15, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 408 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
(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.
Distribution
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
States: Alabama Georgia Massachusetts New Jersey Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0532-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.