Recall Z-1481-2024 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus Corporation of the Americas
Hemostasis Probe, Model: CD-B622LA
| Date | Apr 5, 2024 (initiated Jan 5, 2024) |
| Status | Open, Classified |
| Reason | The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector. |
| Root cause | Employee error |
| Action | On January 30, 2024, the firm notified its only customer of the issue via URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION letters. Actions to be taken by the end user: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact your Regional Customer Service, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected |
| Quantity | 36 units (all OUS) |
| Distribution | International distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE Olympus Surgical Technologies America, Dec 14, 2012 |