Data Foundry

Medical device recalls 2014

BD Vacutainer PST Tubes — Class II medical device recall Z-2634-2014

Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-09-24, distributed in LA, OK, TX. Products were held at improper storage temperature

Recall numberZ-2634-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmFresenius Medical Care Holdings, Inc., Waltham, MA, United States
Recall initiated2014-06-23
Classified2014-09-12
Reported by FDA2014-09-24
Terminated2021-01-29
DistributedLA, OK, TX
Quantity13 units
Lot numbersB011403
Model numbers367960FMC, 87-4544-4

Product

BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Reason for recall

Products were held at improper storage temperature

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2634-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.