Z-2619-2023Class II

MINISCAV (tm) Vacuum Pump

Name: Z-2619-2023 MINISCAV (tm) Vacuum Pump
Creator: R A Medical Services
Published: 2023-08-23
License: https://open.fda.gov/license/

R A Medical Services / initiated 2023-08-23 / Open, Classified / root cause: manufacturing process

FDA source

R A Medical Services began a recall of MINISCAV (tm) Vacuum Pump on 2023-08-23. FDA classified it as Class II and gives the reason as "Inadequate documentation of acceptance activity". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2619-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-23
Posted: 2023-09-20
Recalling firm: R A Medical Services
Product: MINISCAV (tm) Vacuum Pump
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Inadequate documentation of acceptance activity
Root cause tag: manufacturing process
FDA root cause: Process control
Action: R A Medical Services notified the only consignee via email on 08/23/2023. Instructions were to quarantine and return affected units.
Quantity in commerce: 10 units
Distribution: Distribution to Ohio
Product codes and lots: UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2619-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2619-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20

Product code BTA

K160950Class IIMiniscavSedation Systems, LLC / cleared 2017-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)