Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise
CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
CooperSurgical, Inc. is recalling 1,180 units of the Cooper Surgical TAMPA CATHETER 5 French 33 cm (Model Number: 61-2005), intended for hysterosonography. The recall is due to the possibility that the sterility of the device may be compromised because of unsealed pouches.
The affected product, identified by Lot 141525, was distributed nationwide in the United States, including the states of Colorado, Connecticut, Missouri, Vermont, New York, Ohio, New Jersey, Florida, North Carolina, Virginia, Alabama, Massachusetts, Pennsylvania, and California, as well as in Canada.
Consumers and healthcare providers should stop using the affected catheters and contact CooperSurgical, Inc. for further instructions or a return.
The recalled product
- Product
- Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1,180
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)
- Lot 141525
Distribution
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