FDA Enforcement
Class II
Terminated
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.
Recall: Z-2634-2014
·
Reported September 24, 2014
Enforcement
- Recall Number
- Z-2634-2014
- Event ID
- 68585
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 24, 2014
- Initiation Date
- June 23, 2014
- Classification Date
- September 12, 2014
- Termination Date
- January 29, 2021
- Address
- 920 Winter St, N/A, Waltham, MA, 02451-1521, United States
Description
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
Products were held at improper storage temperature
Code Info
Lot: B011403
Distribution
Distributed in the states of LA, OK, and TX.
Quantity
13 Each