Z-2800-2024 Class II Ongoing

Recalled by Beaver Visitec International, Inc. — Waltham, MA

FDA device recall Z-2800-2024 was initiated by Beaver Visitec International, Inc. on Jul 26, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 84 units.

Recall Details

Product Type
Devices
Report Date
Sep 4, 2024
Initiation Date
Jul 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84 units

Product Description

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;

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 Pattern

US Nationwide distribution.

Code Information

Part Number: 58000192; UDI-DI: 30886158009963; Lot/Batch Number: 6071161

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2800-2024
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.