Recall Z-2126-2020 ยท FMH Container, Specimen, Sterile
Thermo Fisher Scientific (Monterrey)
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.
| Date | Apr 29, 2020 |
| Status | Terminated |
| Reason | Product was not irradiated; therefore, they are not sterile and do not meet product specification. |
| Root cause | Material/Component Contamination |
| Action | 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 spe |
| Quantity | 78,600 each (786 cartons, 100 devices/carton) |
| Distribution | US Distribution to states of: IL, KY , TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.