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Terminated

StemPro MSC SFM CTS"

FDA Recall Z-0274-2020 · Posted None

Recalling FirmLife Technologies Corporation
Recall StatusTerminated
Product CodeNDS
Date Initiated2019-06-11
Date Terminated2020-06-04
Product Quantity4724 Kits

Reason for Recall

Component was not tested by the supplier for adventitious agents

Firm 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 [email protected]

Root Cause

Vendor change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103302STEMPRO MSC SFMLife Technologies Corporation · 2011-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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