Device 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.
Z-2434-2015
Product summary
- Event
- Event 71633
- Status
- Terminated
- Classification
- Class III
- Quantity
- 238, 000 (Lot #5133959) and 243,000 (Lot #5133957)
- Official record key
device-enforcement:Z-2434-2015
Official wording
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.
Code information: REF #367986, Lot #'s 5133957 and 5133959
Distribution pattern: Distributed in FL, IL, MA, MI, MO, PA and TN.
Derived failure modes
-
Unknown
Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.