AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Recall
- Recall Number
- Z-2238-2024
- Event Number
- 94702
- Firm
- Applied Medical Technology Inc
- FEI Number
- 1526012
- Product Code
- KNT
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- May 14, 2024
- Posted
- June 28, 2024
- Address
- 8006 Katherine Blvd, Brecksville, OH, 44141-4202
Description
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Devices were labelled with the incorrect guidewire labelling.
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.
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
74 units