Device 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 of procedures.
Z-3278-2018
Product summary
- Event
- Event 81037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,000 units
- Official record key
device-enforcement:Z-3278-2018
Official wording
Reason: There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Code information: Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.