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FDAApril 9, 2020device

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

What to do

FDA enforcement status: Terminated

Brands named

coopersurgical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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