CooperSurgical H/S Catheter Recalled Due to Unsealed Pouches
CooperSurgical is recalling 1,400 H/S Catheters intended for hysterosonography because some pouches were unsealed.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CooperSurgical, Inc. is voluntarily recalling 1,400 units of the H/S Catheter (Part # 61-5007), Lot 153914. The device is intended for use in hysterosonography and hysterosalpingography procedures. The recall was initiated because some product pouches were found to be unsealed.
The affected units were distributed worldwide, including in the United States (specifically in CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC) and in Spain, England, Holland, and the United Kingdom. The recall was initiated on July 3, 2014, and was terminated on May 28, 2015.
Healthcare providers and consumers should stop using the affected catheters and contact CooperSurgical, Inc. for further instructions or a replacement.
The recalled product
- Product
- CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 1,400
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 153914
Distribution
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