MEDLINE INDUSTRIES, LP - Northfield: (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.

Hazard

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Details from the source

Reason for recall: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. Distribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA. Quantity: 408 kits Lot/code info: (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.

UPC codes

10195327245276, 40195327245277, 10195327657154, 40195327657155

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.