medical Class II Updated 2023-12-13

CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administ

Recalled Product

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-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: 61-4005


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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI:60888937016446 S/N: 313121, 313568
View official government recall

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