medical Class II Updated 2018-05-09

Cook Inc. recalls StoneBreaker Single Use Probe, Catalog numbers: SBP-010500;

Recalled Product

StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608

Hazard / Issue

The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots
View official government recall

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