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U.S. Department of Health and Human Services

Class 2 Device Recall Samco BioTite Sterile Specimen Container

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  Class 2 Device Recall Samco BioTite Sterile Specimen Container see related information
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
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
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
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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