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Recall Observatory FDA recall evidence

Device 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.

Z-0532-2025

October 15, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95638
Status
Ongoing
Classification
Class II
Quantity
408 kits
Official record key
device-enforcement:Z-0532-2025

Official wording

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

Code information: (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 pattern: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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