Medical device recalls

Aesculap Implant Systems LLC recalls Doyen-Collin Mouth Gag 120MM/ General Instruments

Recall date
February 16, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1358-2018
FDA classification
Class III
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
nationwide

Why it was recalled

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Doyen-Collin Mouth Gag 120MM/ General Instruments

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