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FDA Medical Device Recalls (openFDA)

R A Medical Services: MINISCAV (tm) Vacuum Pump

Recall number
Z-2619-2023
Recalling firm
R A Medical Services
Product
MINISCAV (tm) Vacuum Pump
Status
Open, Classified
Initiated
2023-08-23
Posted
2023-09-20
Terminated
not on file
Reason
Inadequate documentation of acceptance activity
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
10 units
Distribution
Distribution to Ohio
Lot, serial or model codes
UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523
510(k) numbers
["K160950"]
PMA numbers
not on file
Product code
BTA
Firm FEI
3008460563
Firm city
Keighley
Firm state
not on file
Firm country
United Kingdom

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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