Recalls / —

—#163001

Product

BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog 367344

FDA product code

JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K030573

Affected lot / code info

7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product. If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement. If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern

US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania

Timeline

Recall initiated

2018-03-20

Terminated

2020-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #163001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.