Recall Z-3278-2018 ยท GAD Retractor
CooperSurgical, Inc.
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.
| Date | Sep 4, 2018 |
| Status | Terminated |
| Reason | There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. |
| Root cause | Nonconforming Material/Component |
| 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 produc |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC Lone Star Medical Products, Inc., Sep 19, 1979 |