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.
Recall
- Recall Number
- Z-2126-2020
- Event Number
- 85561
- Firm
- Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico
- FEI Number
- 3007730738
- Product Code
- FMH
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- April 29, 2020
- Terminated
- December 10, 2020
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.
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Thermo Fisher Scientific issued U"RGENT: MEDICAL DEVICE RECALL NOTIFICATION" dated 4/28/20 to First level and second level consignees via email as well as a recall notification letter sent by overnight mail on 4/29/20. Letter states reason for recall, health risk and action to take: Actions Requested: "Examine your inventory to determine if you have any of the above referenced product on-hand. If so, discontinue use immediately and quarantine all affected product. "Notify all affected users in your facility and anyone else you may have distributed or forwarded affected product for the specific lot number. "Please complete the attached Customer Response Sheet, regardless of whether you have affected product on-hand. Indicate the quantity you are returning and whether you are requesting a credit or product replacement and email to [email protected] If you have any questions, call or email Technical Support, at: +1-800-625-4327 or [email protected]
US Distribution to states of: IL, KY , TX
78,600 each (786 cartons, 100 devices/carton)