Recall Z-0098-2019 ยท HEW Culdoscope (And Accessories)
CooperSurgical, Inc.
Colpo-Pneumo Occluder, Part CPO-6
| Date | Sep 4, 2018 |
| Status | Terminated |
| Reason | The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. |
| Root cause | Other |
| Action | Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers do the following: Please be advised that CooperSurgical has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. If any product from the 26 lots is in your possession and has a green label affixed to the outer display box as displayed below, it is not affected by this recall action. A product is acceptable for use if it is visually confirmed that the pouchs seal is intact. As indicated in the Directions for Use (DFU), |
| Quantity | 32538 |
| Distribution | The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954311 | KOH COLPOTOMIZER SYSTEM CooperSurgical, Inc., Nov 19, 1996 |