AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA device recall Z-2238-2024 · posted 2024-06-28 · Completed
Recall details
- Recalling firm
- Applied Medical Technology Inc
- Reason for recall
- Devices were labelled with the incorrect guidewire labelling.
- 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.
- Root cause
- Process control
- Status
- Completed
- Product code
- KNT
- Quantity affected
- 74 units
- Distribution
- US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
- Date initiated
- 2024-05-14
- Date posted
- 2024-06-28
- Location
- Brecksville, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) (K073034) | Applied Medical Technology, Inc. | 2008-03-14 |