The Recall Desk
HighFDA (Devices)·Z-0059-2020·Announced 2019-10-16

BD Microtainer PSTTubes with Lithium Heparin Recalled for Damaged Reservoirs

Becton Dickinson & Company is recalling BD Microtainer PSTTubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall, and the hazard involves a risk of erroneous test results due to improper sample volumes, which fits the criteria for high-risk products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling BD Microtainer PSTTubes with Lithium Heparin, Part/Catalog Number 365985. The recall involves specific lots of the product, including 808592N, 809669N, 811070N, 811071N, 811664N, 813767N, 815060N, 815061N, 815062N, 816499N, 821563N, 821564N, 821565N, 821888N, 827063N, 827064N, 827589N, 827693N, and 827699N. The product was distributed nationwide and to various foreign countries.

The recall was initiated because a damaged reservoir may lead to a decreased fill volume. This issue can cause samples to be insufficient for testing and result in an improper blood-to-additive ratio, potentially producing erroneous results. The FDA has classified this recall as Class II.

Healthcare facilities and consumers should check their inventory for the affected lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or Becton Dickinson & Company according to their instructions.

The recalled product

Product
BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →