CooperSurgical Recalls Colpo-Pneumo Occluder Due to Compromised Sterile Pouch Seal
CooperSurgical is recalling Colpo-Pneumo Occluder devices because the sterile pouch seal may be compromised, increasing the risk of infection.
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 infection from a compromised sterile seal, which is a significant health hazard, but no specific injuries or illnesses are reported in the source text, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
CooperSurgical, Inc. is recalling the Colpo-Pneumo Occluder, Part CPO-6, due to a potential defect in the sterile pouch seal. The compromised seal may increase the risk of infection for patients using the device.
The recall affects 32,538 units distributed across 48 U.S. states and the District of Columbia, as well as 21 foreign countries. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and patients should stop using the affected devices and contact CooperSurgical for further instructions or replacement.
The recalled product
- Product
- Colpo-Pneumo Occluder, Part CPO-6
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Surgical Device
- Affected units
- 32,538
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 (20)
- Lots 244131
- 244132
- 244670
- 244671
- 244887
- 244888
- 244889
- 244890
- 245228
- 245325
- 245326
- 245327
- 245613
- 245614
- 245615
- 245976
- 245977
- 245978
- 245979
- 246810
Distribution
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