AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
- Company
- Applied Medical Technology Inc
- Recall Initiated
- May 14, 2024
- Posted
- June 28, 2024
- Recall Number
- Z-2238-2024
- Quantity
- 74 units
- Firm Location
- Brecksville, OH
Reason for Recall
Devices were labelled with the incorrect guidewire labelling.
Distribution
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Lot / Code Info
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Root Cause
Process control
Action Taken
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 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.