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Terminated

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.

FDA Recall Z-3278-2018 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeGAD
Date Initiated2018-09-04
Date Terminated2020-04-15
Product Quantity18,000 units

Reason for Recall

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

Firm Action

Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers to do the following: Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you have no affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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