Velano PIVO Blood Collection Device 20G units recalled for incomplete package sealing
Velano Vascular is recalling 123,700 PIVO Blood Collection Device 20G units due to incomplete package sealing that could compromise sterile barriers and allow microbial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with potential for serious adverse health outcomes (bloodstream infection) but no reported illnesses, injuries, or deaths. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Velano Vascular is recalling 123,700 PIVO Blood Collection Device 20G units (reference 202-0005, UDI 00850984007027). The recalled devices were distributed nationwide. The affected lot codes are 070621-02, 062221-01, 061021-02, 052721-03, and 051421-02.
The recall is due to potential incomplete sealing of blood collection device unit packages. This could breach the sterile barrier enclosing the product, potentially allowing microbial contamination of the device prior to use.
Potential health effects range from no clinical effect up to bloodstream infection. No illnesses or injuries related to this issue have been reported to date.
The recalled product
- Product
- PIVO Blood Collection Device 20G, REF: 202-0005
- Manufacturer
- Velano Vascular
- Affected units
- 123,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI: 00850984007027. Lots: 070621-02
- 062221-01
- 061021-02
- 052721-03
- 051421-02
Distribution
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