Z-0527-2022Class II

PIVO Blood Collection Device 20G, REF: 202-0005

Name: Z-0527-2022 PIVO Blood Collection Device 20G, REF: 202-0005
Creator: Velano Vascular
Published: 2021-11-10
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2021-11-10 / Terminated / root cause: manufacturing process

FDA source

Velano Vascular began a recall of PIVO Blood Collection Device 20G, REF: 202-0005 on 2021-11-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0527-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-10
Posted: 2022-01-25
Terminated: 2023-07-31
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: PIVO Blood Collection Device 20G, REF: 202-0005
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/10/21, recall notices were sent to Medical Directors, Risk Managers, Medical Device Safety Officers, Nurse Managers. 1) Locate and destroy all product subject to the recall following your institution s process for destruction. 2) If the affected product was previously used in patient care and no signs of infection are apparent, no additional steps need to be taken. If the affected product was used in patient care and signs of infection are present, follow your institution s established procedures. 3) Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. If you further distributed product, identify customers within your distribution network that purchased the affected product, as defined in this recall notification. Email an excel file listing of all customers to [email protected] so the recalling firm may initiate customer notification. 4) Complete and return the Distributor Response Form. Customers require further assistance are encouraged to call/email: 1-844-823-5433/ [email protected]
Quantity in commerce: 123,700
Distribution: US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Product codes and lots: UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0527-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-25

Product code JKA

K193569Class IIPivo(tm)Velano Vascular / cleared 2020-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)