Skip to content
Recall Observatory FDA recall evidence

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

September 04, 2018

Class II

Product summary

Firm
CooperSurgical, Inc.
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

    reason.no_named_rule · v1.0.0

    There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.