FDA Enforcement
Class II
Ongoing
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;
Recall: Z-2836-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2836-2024
- Event ID
- 95068
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beaver Visitec International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- July 26, 2024
- Classification Date
- August 28, 2024
- Address
- 500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States
Description
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;
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.
Code Info
Part Number: 58001014; UDI-DI: 30886158021729; Lot/Batch Number: 6071020, 6075094
Distribution
US Nationwide distribution.
Quantity
424 units