PIVO Blood Collection Device 20G, REF: 202-0005
Check against the official notice below — it lists the full affected range.
Velano Vascular is recalling 123,700 units of its PIVO Blood Collection Device (20G, REF: 202-0005) because some unit packages may not be completely sealed. An incomplete seal can allow bacteria to contaminate the sterile device before it is used. Potential health effects from contamination range from no clinical effect to bloodstream infection. The affected product was distributed nationwide across Connecticut, Colorado, Utah, Pennsylvania, Illinois, Washington, California, New Jersey, Michigan, Florida, and North Carolina.
The recall affects specific lot numbers: 070621-02, 062221-01, 061021-02, 052721-03, and 051421-02, which can be identified by the UDI 00850984007027. The source document does not specify what action affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.
Reason for recall: Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection. Distribution: US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC. Quantity: 123,700 Lot/code info: UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.