MINISCAV Vacuum Pump Recalled for Inadequate Acceptance Documentation
R A Medical Services has recalled 10 MINISCAV Vacuum Pump units distributed in Ohio due to inadequate documentation of the product acceptance activity during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II recall involves a documentation and quality control deficiency rather than a reported device defect or patient harm. As no illnesses or injuries have been reported and the hazard is procedural in nature, the severity is Moderate.
Plain-English summary
The MINISCAV (tm) Vacuum Pump manufactured by R A Medical Services is the subject of a Class II recall. Ten units with serial numbers N/AB/10514 through N/AB/10523 were distributed in Ohio.
The recall was issued due to inadequate documentation of acceptance activity during the manufacturing process. This procedural deficiency affects the verification of whether the devices meet established quality standards.
Patients and healthcare facilities in Ohio who have received these devices should contact R A Medical Services or their healthcare provider. No illnesses or injuries have been reported in connection with these devices.
The recalled product
- Product
- MINISCAV (tm) Vacuum Pump
- Manufacturer
- R A Medical Services
- Category
- Medical Device — Vacuum Pump
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523
Distribution
Distributed in 1 state:
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