Recall Z-0504-2024— CooperSurgical, Inc.

Name: FDA recall Z-0504-2024
Creator: U.S. Food and Drug Administration
Published: 2022-03-31

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2022-03-31. It names one FDA 510(k) clearance: K013972. 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. Reason: 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.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-31
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K013972 — H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005Ackard Laboratories·cleared 2001-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.