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Recall Observatory FDA recall evidence

Device product

FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..

Z-0718-2025

November 06, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95806
Status
Ongoing
Classification
Class II
Quantity
36 kits
Official record key
device-enforcement:Z-0718-2025

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: 10195327050146(each), 40195327050147(case); Lot Number: 23HMB316

Distribution pattern: US Nationwide. Canada.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification