Recall Z-2291-2018 ยท GFD Dermatome
Exsurco Medical
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
| Date | Apr 17, 2018 |
| Status | Terminated |
| Reason | Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst. |
| Root cause | Use error |
| Action | On April 17, 2018 Exsurco Medical hand delivered notices to customers. Customers were advised to take the following actions: -Review, complete and return the Customer Response Card. -Upon verifying the information, provide the information to all Burn Account Managers. -An Exsurco Field Service Technician will perform the correction. Starting July 1, 2018, Exsurco Medical will issue URGENT Medical Device Recall notices and response cards to Burn Account Managers via certified mail or by hand delivery. Exsurso Medical will also provide replacement hoses simultaneously. Burn Account Managers |
| Quantity | 70 coaxial hoses |
| Distribution | CA, GA, MO, OH & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.