FDA Enforcement
Class II
Terminated
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.
Recall: Z-2631-2014
·
Reported September 24, 2014
Enforcement
- Recall Number
- Z-2631-2014
- 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 SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.
Reason
Products were held at improper storage temperature
Code Info
Lot(s): 3305588 and 4006903
Distribution
Distributed in the states of LA, OK, and TX.
Quantity
9 boxes