| | Class 2 Device Recall CARDINAL HEALTH brand |  |
| Date Initiated by Firm | July 18, 2019 |
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| Create Date | November 01, 2019 |
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| Recall Status1 |
Terminated 3 on May 18, 2020 |
| Recall Number | Z-0273-2020 |
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| Recall Event ID |
83762 |
| Product Classification |
Container, specimen, sterile - Product Code FMH
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| Product | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk)
Catalog number: CHB13905 |
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| Code Information |
Lot # 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, 1252504 |
Recalling Firm/
Manufacturer |
Thermo Fisher Scientific (Monterrey)
Blvd Apodaca 500
Apodaca Technology Park
Apodaca Nuevo Leon 66600 Mexico
|
Manufacturer Reason
for Recall | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial |
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FDA Determined
Cause 2 | Equipment maintenance |
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| Action | 1. Please notify to any organizations that have received affected product.
2. If you have any affected product please contact Technical Support Team regarding free-of-charge product replacement.
Technical Support:
Phone - +1-800-625-4327
Email - technicalsupport@thermofisher.com |
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| Quantity in Commerce | 514,200 each |
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| Distribution | OH |
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| 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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