Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
FDA Recall Z-2291-2018 · Posted None
Recalling FirmExsurco Medical
Recall StatusTerminated
Product CodeGFD
Date Initiated2018-04-17
Date Terminated2020-06-15
Product Quantity70 coaxial hoses
Reason for Recall
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.
Firm 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 are advised to take the following actions:
-Review, complete and return the Customer Response Card.
-Replace all impacted X101004 Pneumatic Hoses with replacement hoses.
-Discard impacted X101004 Pneumatic Hoses as outlined in the recall notification.
Should you have any questions regarding this matter please contact (440) 204-3239/ email: [email protected].
Root Cause
Use error
Distribution Pattern
CA, GA, MO, OH & TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.