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U.S. Department of Health and Human Services

Class 2 Device Recall PIVO(TM)

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  Class 2 Device Recall PIVO(TM) see related information
Date Initiated by Firm November 10, 2021
Create Date January 25, 2022
Recall Status1 Terminated 3 on July 31, 2023
Recall Number Z-0527-2022
Recall Event ID 89185
510(K)Number K193569  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product PIVO Blood Collection Device 20G, REF: 202-0005
Code Information UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
Recalling Firm/
Manufacturer		 Velano Vascular
221 Pine St # 200
San Francisco CA 94104-2705
For Additional Information Contact
844-835-2668
Manufacturer 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.
FDA Determined
Cause 2		 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 BDRC9@bd.com 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/ productcomplaints@bd.com
Quantity in Commerce 123,700
Distribution US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = Velano Vascular
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