Cannula, Manipulator/injector, Uterine

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pat

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

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine

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

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet

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

Mckesson GYNECATH H/S CATHETER 5FR (10/CS)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators

Design of device may expose user to injury to fingers or body parts

CooperSurgical H/S CATHETER (PART # 61-5007)

Unsealed pouches.

Cooper Surgical TAMPA CATHETER 5 French 33 cm.

Sterility of the device may be compromised due to unsealed pouch

Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South,

Inadequate package seal could compromise sterility.