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U.S. Department of Health and Human Services

Class 2 Device Recall StemPro MSC SFM CTS"

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 Class 2 Device Recall StemPro MSC SFM CTS"see related information
Date Initiated by FirmJune 11, 2019
Create DateNovember 06, 2019
Recall Status1 Terminated 3 on June 04, 2020
Recall NumberZ-0274-2020
Recall Event ID 83301
510(K)NumberK103302 
Product Classification Media, culture, ex vivo, tissue and cell - Product Code NDS
ProductStemPro MSC SFM CTS"
Code Information SKU#: A1033301;  Lot # 556094 (Exp 2/28/2010), 577934 (Exp 4/30/2010) , 883643 (Exp 12/30/2011), 987595 (Exp 6/30/2013), 1607880 (Exp 6/30/2016), 1936294 (Exp 11/30/2019), 1960237 (Exp 4/30/2020), 2015107 (Exp 10/30/2020), 2049317 (Exp 11/30/2020), 2074105 ( Exp2/28/2021)
Recalling Firm/
Manufacturer		 Life Technologies Corporation
3175 Staley Rd
Grand Island NY 14072-2028
For Additional Information ContactLeah 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
Action1. 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 Commerce4724 Kits
DistributionStemPro¿ 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.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = NDS
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