Recall Z-2291-2018— Exsurco Medical
Class II · Terminated
Class II FDA medical device recall by Exsurco Medical, initiated 2018-04-17, terminated 2020-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004. 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..
- Recalling firm
- Exsurco Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-17
- Terminated
- 2020-06-15
- Firm location
- Wakeman, OH, United States
Product description
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.