Z-2126-2020 Class II Terminated
FDA device recall Z-2126-2020 was initiated by Thermo Fisher Scientific (Monterrey) on April 29, 2020 and is designated Class II. Reason for recall: Product was not irradiated; therefore, they are not sterile and do not meet product specification. The recall status is terminated (terminated December 10, 2020). Affected quantity: 78,600 each (786 cartons, 100 devices/carton).
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 29, 2020
- Termination Date
- December 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78,600 each (786 cartons, 100 devices/carton)
Product Description
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
Reason for Recall
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Distribution Pattern
US Distribution to states of: IL, KY , TX
Code Information
Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4