Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
FDA Recall Z-0170-2018 · Posted None
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Recalling FirmShippert Medical Technologies
Recall StatusTerminated
Product CodeMUU
Date Initiated2017-10-20
Date Terminated2018-10-09
Product Quantity56 units
Reason for Recall
Potential breach of sterility of the packaging.
Firm Action
A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution -- United States, Australia, and Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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