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Terminated

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.

FDA Recall Z-2434-2015 · Posted 2015-08-20

Recall StatusTerminated
Product CodeJKA
Date Initiated2015-06-23
Date Terminated2016-04-06
Product Quantity238, 000 (Lot #5133959) and 243,000 (Lot #5133957)

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.

Firm Action

Becton Dickinson notified their affected customers of this recall by sending them an Urgent Product Recall Letter dated June 23, 2015 via UPS 2nd Day.

Root Cause

Process control

Distribution Pattern

Distributed in FL, IL, MA, MI, MO, PA and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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