FDA Enforcement
Class II
Terminated
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
Recall: Z-2633-2014
·
Reported September 24, 2014
Enforcement
- Recall Number
- Z-2633-2014
- 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 Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
Reason
Products were held at improper storage temperature
Code Info
Lot: 4007362
Distribution
Distributed in the states of LA, OK, and TX.
Quantity
2 each