FDA recall Z-0532-2025

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-10-15

Report date

2024-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2025