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Recall Observatory FDA recall evidence

Device product

Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A

Z-0721-2025

November 06, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95806
Status
Ongoing
Classification
Class II
Quantity
318 kits
Official record key
device-enforcement:Z-0721-2025

Official wording

Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

Code information: UDI-DI: DYNJ21927R, 10195327104733(each), 40195327104734(case); Lot Number: 23IBF547 23GBT501 23FBU360 23EBU929 23EBL624 23EBA114 23CBN730 23ABF393 22JBK203 22IBN858 22HBO301 22GBC794 22CBI774; UDI-DI: DYNJ910120A, 10195327689872 (each), 40195327689873 (case), Lot Numbers: 24HMK254

Distribution pattern: US Nationwide. Canada.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification