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BVI CustomEyes Procedure Packs containing Sol-M Luer Lock… recallZ-2926-2024 · Beaver Visitec International, Inc. · initiated Jul 26, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beaver Visitec International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: No Marketing Application

What the company is doing

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 letter when contacting your customers. 3. Please follow the attached instructions for placing the recall labels on the products containing Sol-M syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact [email protected]. Product may be returned to inventory once properly over-labeled. Refer to Appendix 2 Over labeling Instructions 4. At the point of clinical use, the Sol-M syringes are to be discarded. Photographs of Sol-M syringes are enclosed to assist in identification. Appendix 3 Images 5. Ensure that appropriate personnel within your organization are made aware of this field action 6. To maintain awareness, we suggest to post this URGENT MEDICAL DEVICE RECALL NOTICE and Sol-M syringe photographs on or near the affected products in your inventory location 7. Please fill out, scan and email the completed Business Response Form to BVI Sedgwick at [email protected] within seven (7) days BVI is committed to providing high quality products to you and apologizes for any inconvenience this field action may cause. If you have any questions, please reach out to your Sales Representative.

Recall details

Recall number
Z-2926-2024
Status
Open, Classified
Initiated by the company
Jul 26, 2024
Posted by the FDA
Aug 28, 2024
Recalling firm
Beaver Visitec International, Inc.
Quantity
102 units
Product code
KDD
Distribution
US Nationwide distribution.

Product description

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;

Code information (models, lots, serial numbers)

Part Number: 58001934; UDI-DI: 30886158033562; Lot/Batch Number: 6070801

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95068).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page