CooperSurgical, Inc. recalls CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet
Recalled Product
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S 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
Hazard / Issue
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
Issued by
FDA
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