Date Initiated by Firm | April 29, 2020 |
Create Date | May 26, 2020 |
Recall Status1 |
Terminated 3 on December 10, 2020 |
Recall Number | Z-2126-2020 |
Recall Event ID |
85561 |
Product Classification |
Container, specimen, sterile - Product Code FMH
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Product | 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. |
Code Information |
Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4 |
Recalling Firm/ Manufacturer |
Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico
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For Additional Information Contact | John Winter 612-4990066 |
Manufacturer Reason for Recall | Product was not irradiated; therefore, they are not sterile and do not meet product specification. |
FDA Determined Cause 2 | 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 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 technicalsupport@thermofisher.com
If you have any questions, call or email Technical Support, at: +1-800-625-4327 or technicalsupport@thermofisher.com |
Quantity in Commerce | 78,600 each (786 cartons, 100 devices/carton) |
Distribution | US Distribution to states of: IL, KY , TX |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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