FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Pneupac paraPac plus 300 ventilator kit, REF P300NGB
- Recall number
- Z-0163-2022
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Pneupac paraPac plus 300 ventilator kit, REF P300NGB
- Status
- Terminated
- Initiated
- 2021-07-15
- Posted
- not on file
- Terminated
- 2023-08-11
- Reason
- Two devices were labeled with the same serial number
- Root cause
- Process control
- Action
- The firm notified the consignee by email on 07/15/2020 and requested the return of the units.
- Quantity
- 2 units
- Distribution
- UK
- Lot, serial or model codes
- SN RF70121
- 510(k) numbers
- ["K123957"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
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