AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA Recall Z-2238-2024 · Posted 2024-06-28
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Recalling FirmApplied Medical Technology Inc
Recall StatusCompleted
Product CodeKNT
Date Initiated2024-05-14
Product Quantity74 units
Reason for Recall
Devices were labelled with the incorrect guidewire labelling.
Firm Action
Consignees were mailed an URGENT: MEDICAL DEVICE RECALL letter, dated 5/14/24. Consignees are instructed to not use recalled product and complete the provided acknowledgement form to coordinate return of affected devices by fax to 440-717-4200 or by email to [email protected]. The firm will replace or refund any affected devices returned. Consignees are instructed to continue inspecting product prior to its use according to the IFU and good medical practices. Consignees with any questions can contact the firm by phone at 440-717-4000 from the hours of 8:30 AM to 5:00 PM EST.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
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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