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Recall Observatory FDA recall evidence

Device product

Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

Z-2649-2023

May 23, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92883
Status
Ongoing
Classification
Class II
Quantity
106 units
Official record key
device-enforcement:Z-2649-2023

Official wording

Reason: The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

Code information: Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.