FDAFDA · Food and drugs·Recall number Z-0532-2025
(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.
Published December 4, 2024 · Recall initiated: October 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
- Lot
- (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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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