| Class 2 Device Recall CTSTM Essential 8 Medium | |
Date Initiated by Firm | June 11, 2019 |
Create Date | November 06, 2019 |
Recall Status1 |
Terminated 3 on June 04, 2020 |
Recall Number | Z-0275-2020 |
Recall Event ID |
83301 |
Product Classification |
unknown device name - Product Code N/A
|
Product | CTSTM Essential 8 Medium |
Code Information |
SKU: A2656001 Lot: 1955886 (Exp1/30/2019), 1960951 (Exp1/30/2019), 2039735 (Exp1/30/2020) |
Recalling Firm/ Manufacturer |
Life Technologies Corporation 3175 Staley Rd Grand Island NY 14072-2028
|
For Additional Information Contact | Leah Arruda 760-268-7494 |
Manufacturer Reason for Recall | Component was not tested by the supplier for adventitious agents |
FDA Determined Cause 2 | Vendor change control |
Action | 1. Examine your inventory immediately to determine if you have any of the referenced material on hand.
2. If so, discontinue use immediately and discard per your local laws and regulations.
3. Notify all affected users in your facility.
4. If you have shipped this lot outside of your facility, notify those customers or facilities of this recall.
To EMEA cutomers: please complete the customer response sheet if you have confirmed visual evidence of media between the media bag and dust cover in your material.
Email a copy of the response sheet along with the recall letter to your local order support team.
If you have nay question, please call Technical support at 00 800 5345 5345 option 3 or email at eurotech@thermofisher.com |
Quantity in Commerce | 3693 Kits |
Distribution | StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI.
StemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Malaysia, Netherlands, Pakistan, Poland, Republic of Korea, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam.
CTSTM Essential 8 Medium distributed to the following states in the USA: CA, DC, FL, IA, IL, MA, MD, MN, NC, NY, WA, WI.
CTSTM Essential 8 Medium distributed Internationally to the following countries: Australia, Canada, China, France, Germany, India, Japan, Netherlands, Portugal, Republic of Korea, Saudi Arabia, Singapore, Sweden, Switzerland, Taiwan, United Kingdom. |
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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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