| Date Initiated by Firm | June 04, 2018 |
|---|
| Create Date | August 11, 2018 |
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| Recall Status1 |
Terminated 3 on June 07, 2019 |
| Recall Number | Z-2749-2018 |
|---|
| Recall Event ID |
80584 |
| Product Classification |
Cytocentrifuge - Product Code IFB
|
| Product | EZ Single Cytofunnel Brown, A78710004
Product Usage:
The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin. |
|---|
| Code Information |
Lot # 17269A0 |
| FEI Number |
1831638
|
Recalling Firm/
Manufacturer |
Richard-Allan Scientific Company
4481 Campus Dr
Kalamazoo MI 49008-2590
|
Manufacturer Reason
for Recall | Mislabeled product |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
|---|
| Action | On June 4, 2018, ThermoFisher Scientific issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to inspect stock, quarantine, safely dispose or return impacted product. Evidence of disposal is required to be sent to Thermo Shandon Limited. If affected product has been used with no issues, please notify Thermo Shandon Limited of the quantity that is unavailable for disposal. Complete and return the Recall Return Response Acknowledgement & Receipt form via email to marganne.miller@thermofisher.com |
|---|
| Quantity in Commerce | 1,039 cases/40 boxes per case |
|---|
| Distribution | US Nationwide Distribution |
|---|
| Total Product Life Cycle | TPLC 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.
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