Recall Z-2434-2015— Becton Dickinson & Company

Class III · Terminated

Class III FDA medical device recall by Becton Dickinson & Company, initiated 2015-06-23, terminated 2016-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.. Reason: Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time..

Recalling firm
Becton Dickinson & Company
Classification
Class III
Status
Terminated
Initiated
2015-06-23
Terminated
2016-04-06
Firm location
Franklin Lakes, NJ, United States

Product description

BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.

Reason for recall

Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.

Data sourced from openFDA. This site is unofficial and independent of the FDA.