Recall Z-2619-2023
R A Medical Services · initiated August 23, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MINISCAV (tm) Vacuum Pump
Codes / lots: UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523
Reason for recall
Inadequate documentation of acceptance activity
FDA-determined cause: Process control
Action taken
R A Medical Services notified the only consignee via email on 08/23/2023. Instructions were to quarantine and return affected units.
Details
- Recall number
- Z-2619-2023
- Initiated
- August 23, 2023
- Posted by FDA
- September 20, 2023
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 10 units
- Distribution
- Distribution to Ohio
- Recalling firm
- R A Medical Services, Keighley