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Recall Observatory FDA recall evidence

Device product

Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

Z-0789-2025

November 21, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95852
Status
Ongoing
Classification
Class II
Quantity
1494 units
Official record key
device-enforcement:Z-0789-2025

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 DYNJ80585A, UDI/DI 10195327063948 (EA) 40195327063949 (CS), Lot Numbers: 22ABF513, 22DBK159, 22DBL699, 22FBQ597; 2) REF DYNJ80585B, UDI/DI 10195327211158 (EA), 40195327211159 (CS), Lot Numbers: 22GBV101, 22HBG177, 22HBU871, 23ABD760, 23BBE037, 23GBL753, 23GBV443, 23HBU815, 23IBJ525, 23JBO457, 23LBD006, 24BBC495, 24CBI323, 24DBJ068, 24DBP653, 24EBP712, 24FBM276, 24IBG473.

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.