Retractor System Elastic Stays recall
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…
Why was Retractor System Elastic Stays recalled?
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
- 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…
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 18,000 units
- Distribution
- Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.
- Recall date
- October 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)