Recall Z-2250-2025 ยท OKV Obstetrical Kit
AVID Medical, Inc.
GYN LAPAROSCOPY PACK. Medical convenience kit.
| Date | Aug 4, 2025 (initiated Jun 11, 2025) |
| Status | Open, Classified |
| Reason | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. |
| Root cause | Under Investigation by firm |
| Action | Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com |
| Quantity | 346 units |
| Distribution | Domestic: CA, IL, MD, OH, PA, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.