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Recall Observatory FDA recall evidence

Device product

Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device

Z-2428-2023

July 13, 2023

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 92561
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2428-2023

Official wording

Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

Code information: UDI/DI 10885403161513, Lot Numbers: B23, C23

Distribution pattern: US and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.