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Recall Observatory FDA recall evidence

Device product

Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120

Z-0780-2025

November 21, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95852
Status
Ongoing
Classification
Class II
Quantity
74 units
Official record key
device-enforcement:Z-0780-2025

Official wording

Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Code information: 1) REF DYNJ69476, UDI/DI 10193489947786 (EA) 40193489947787 (CS), Lot Numbers: 21HDB296; 2) REF DYNJ910120, UDI/DI 10195327589202 (EA) 40195327589203 (CS), Lot Numbers: 24CMH776.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.