Date Initiated by Firm | August 24, 2018 |
Create Date | October 17, 2018 |
Recall Status1 |
Terminated 3 on April 29, 2020 |
Recall Number | Z-0172-2019 |
Recall Event ID |
81052 |
Product Classification |
Media and components, synthetic cell and tissue culture - Product Code KIT
|
Product | Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use
SKU 14040141 |
Code Information |
Lot# 1994520 Exp. date: 30-Jun-2021 (UDI 10190302002691) |
Recalling Firm/ Manufacturer |
Life Technologies, Corp. 3175 Staley Rd Grand Island NY 14072-2028
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For Additional Information Contact | Chance Lai 240-379-4394 |
Manufacturer Reason for Recall | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Thermo Fisherr issued Urgent Medical Device Recall Notification Letter with a customer response sheet sent to consignees via FedEx on 24-Aug-2018.
Consignees have been instructed to discard affected product per local and state requirements, or return the affected product to Thermo Fisher Scientific. All consignees are instructed to complete the attached Customer Response Sheet. Thermo Fisher Scientific will issue a no-cost replacement for the recalled product.
In addition, consignees are instructed to review results and laboratory reporting associated with use of the affected product for further action. Consignees should notify any personnel who need to be aware of the potential for failure of performance for this product. Questions: contact Technical Services Department at 800-955-6288 Option 2. |
Quantity in Commerce | 240 units |
Distribution | Nationwide:
Foreign: Argentina
Australia
Canada
China
Great Britain
Hong Kong
India
Japan
Mexico
Netherlands
New Zealand
Singapore
South Korea
Taiwan |
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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