CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
BVI CustomEyes Procedure Packs recalled by Beaver Visitec International
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes, distributed nationwide in the US. The recall was initiated on 26 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2872-2024
- FDA event ID
- 95068
- Recalling firm
- Beaver Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jul 2024
- FDA classified
- 28 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 26 Jul 2024 | Recall initiated by company | |
| 28 Aug 2024 | Classified by FDA | +33 days |
| 4 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001467;
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes recalled?
Yes. Beaver Visitec International recalled BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes on 26 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-2872-2024.
Why was it 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.
Which lots are affected?
Part Number: 58001467; UDI-DI: 30886158024409; Lot/Batch Number: 6071209
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beaver Visitec International
All 194| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BVI Leos Laser and Endoscopy System recalled | Beaver-Visitec International | Manufacturing (CGMP) Deviations | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
| Device | CLASS II | BVI CustomEyes Procedure Packs recalled by Beaver Visitec International | Beaver Visitec International | Other | Nationwide |
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