Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
FDA Recall Z-1969-2023 · Posted 2023-06-15
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Recalling FirmGalt Medical Corporation
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2023-05-08
Product Quantity6036
Reason for Recall
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
Firm Action
On 5/5/23, recall notices were sent to customers who were asked to do the following:
1) Identify and segregate the affected lot(s) that are in your possession as well as those in the possession of your end-users.
2) Complete and return the field correction reply form to [email protected]
2) Return affected product to the recalling firm.
Customers with questions can email: [email protected]
Root Cause
Process design
Distribution Pattern
Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.
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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