PlainRecalls
FDA Devices Moderate Class II Terminated

BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364

Reported: May 2, 2018 Initiated: March 20, 2018 #Z-1533-2018

Product Description

BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364

Reason for Recall

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

Details

Units Affected
N/A
Distribution
US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364. Recalled by Becton Dickinson & Company. Units affected: N/A.
Why was this product recalled?
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1533-2018.