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FDAMarch 31, 2022device

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005

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

The hazard

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

What to do

FDA enforcement status: Ongoing

Brands named

coopersurgical

UPCs

60888937016408

Recall history

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

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