Recall Z-0798-2020 ยท HIH Hysteroscope (And Accessories)
CooperSurgical, Inc.
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic
| Date | Dec 13, 2019 |
| Status | Terminated |
| Reason | Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). |
| Root cause | Other |
| Action | On December 13, 2019 the firm sent out letters via Fed-Ex stating the following: URGENT: MEDICAL DEVICE RECALL COOPERSURGICAL ENDOSEE CANNULA Dear Valued CooperSurgical Customer, CooperSurgical is issuing a Medical Device Recall for two lot numbers (268748 & 269360) of its ENDOSEE Advance Cannula (CooperSurgical part number: ESPX5) (the Product), because the finished seal (opposite the chevron seal) of the sterile pouch may be compromised, thereby increasing the risk of infection. The Product is an Ethylene Oxide (ETO) sterilized, single-use, disposable cannula, which is sold in 5 Units/box. |
| Quantity | 460 |
| Distribution | US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190639 | Endosee System CooperSurgical, Inc., May 15, 2019 |