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U.S. Department of Health and Human Services

Class 2 Device Recall AMT Initial Placement Dilator Set

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 Class 2 Device Recall AMT Initial Placement Dilator Setsee related information
Date Initiated by FirmMay 14, 2024
Date PostedJune 28, 2024
Recall Status1 Completed
Recall NumberZ-2238-2024
Recall Event ID 94702
510(K)NumberK073034 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductAMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Code Information Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
FEI Number 1526012
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8006 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information ContactDan Filler
440-7174000
Manufacturer Reason
for Recall		Devices were labelled with the incorrect guidewire labelling.
FDA Determined
Cause 2		Process control
ActionConsignees 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 cs@appliedmedical.net. 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.
Quantity in Commerce74 units
DistributionUS Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = KNT
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