Recall Z-1200-2023 ยท KDD Kit, Surgical Instrument, Disposable
Beaver Visitec International, Inc.
CustomEyes kits
| Date | Mar 1, 2023 (initiated Dec 20, 2022) |
| Status | Open, Classified |
| Reason | Device packaging may contain open seals, compromising product sterility. |
| Root cause | Process control |
| Action | A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com. |
| Quantity | 4640 units in total |
| Distribution | US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.