Recall Z-2238-2024 ยท KNT Tubes, Gastrointestinal (And Accessories)
Applied Medical Technology Inc
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
| Date | Jun 28, 2024 (initiated May 14, 2024) |
| Status | Completed |
| Reason | Devices were labelled with the incorrect guidewire labelling. |
| Root cause | Process control |
| 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 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 | 74 units |
| Distribution | US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073034 | AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) Applied Medical Technology, Inc., Mar 14, 2008 |