FDA recall Z-2802-2024

Product

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000266;

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-07-26

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2802-2024