Medical Catheter Sets Recalled Due to Bonding Material Defect
CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a structural manufacturing defect that poses a risk of harm (component detachment, leakage) during a medical procedure. No injuries or illnesses have been reported to date, which places it at Score 3 per the rubric criteria for risk-of-harm products without reported incidents.
Plain-English summary
CooperSurgical, Inc. is recalling H/S Catheter Sets, Model 61-4005S, used during hysterosalpingography and hysterosonography procedures. These procedures are performed to detect uterine pathology such as polyps, fibroids, adhesions, endometrial thickening, or to assess fallopian tube patency.
The recall is due to incorrect bonding material used during assembly of the catheter sets. This defect may result in detachment of component parts, broken components, or leakage, potentially delaying the diagnostic procedure.
Approximately 90 units of the affected catheter sets have been distributed nationwide and to Belgium, Canada, Malaysia, Netherlands, Spain, Sweden, and Switzerland. The affected product is identified by UDI-DI 60888937016453 with serial number 309967.
Patients and healthcare providers who have received or used this product should contact CooperSurgical for instructions on replacement or return of the affected units. No injuries or adverse events related to this recall have been reported to date.
The recalled product
- 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
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 60888937016453 S/N: 309967
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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