FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: PORT-A-CATH II POWER P.A.C. Low Profile" system.
- Recall number
- Z-2499-2020
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- PORT-A-CATH II POWER P.A.C. Low Profile" system.
- Status
- Terminated
- Initiated
- 2020-06-11
- Posted
- not on file
- Terminated
- 2021-01-25
- Reason
- Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
- Root cause
- Under Investigation by firm
- Action
- Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter.
- Quantity
- 46 kits
- Distribution
- Domestic Distribution: AR, CT, MS,TN,TX
- Lot, serial or model codes
- Lot 3921849.
- 510(k) numbers
- ["K072657"]
- PMA numbers
- not on file
- Product code
- LJT
- 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