medical Class II Updated 2018-10-03

CooperSurgical, Inc. recalls Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
View official government recall

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