Recall Z-2921-2024 ยท KDD Kit, Surgical Instrument, Disposable
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;
| Date | Aug 28, 2024 (initiated Jul 26, 2024) |
| Status | Open, Classified |
| Reason | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs. |
| Root cause | No Marketing Application |
| Action | On July 27, 2024 URGENT FIELD SAFETY NOTICE letters were sent to consignees. Actions required of you 1. Please immediately determine if any of the affected CustomEyes Procedure Packs are within your facility. In such case, quarantine them, and discontinue use until correct recall labels are applied. Please refer to Appendix 1 CustomEyes Procedure Packs List 2. If you have further distributed this product, please notify your customers by initiating a subrecall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification |
| Quantity | 79 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.