CooperSurgical Retractor System Elastic Stays Recalled for Potential Seal Compromise
CooperSurgical is recalling 18,000 units of Retractor System Elastic Stays because the sterile pouch seal may be compromised, increasing the risk of infection.
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: The recall involves a risk-of-harm product (infection risk due to compromised sterile seal) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
CooperSurgical, Inc. is recalling 18,000 units of Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG). These sterile, single-use medical devices are used to provide retraction for optimal visualization during various procedures. The recall involves specific lots: 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
The recall was initiated because there is a possibility that the seal of the sterile pouch may be compromised. This defect increases the risk of infection for patients using the devices. The affected products were distributed worldwide, including nationwide in the United States and in several foreign countries such as Australia, Canada, Germany, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected lots immediately. CooperSurgical is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety o
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 18,000
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 (11)
- Lots 244660
- 245964
- 250426
- 251395
- 244667
- 244883
- 244884
- 245603
- 245973
- 246138
- & 248871
Distribution
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