FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: smiths medical portex Loss of Resistance Device, REF 100/398/000
- Recall number
- Z-0152-2022
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- smiths medical portex Loss of Resistance Device, REF 100/398/000
- Status
- Terminated
- Initiated
- 2020-12-08
- Posted
- not on file
- Terminated
- 2023-08-04
- Reason
- The labeling was missing information on sterilization and prohibition of reuse.
- Root cause
- Error in labeling
- Action
- The firm notified their consignees of the recall by email on 12/08/2021. Distributors were directed to notify their consignees. The firm is seeking return of the product.
- Quantity
- 3420 devices
- Distribution
- Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
- Lot, serial or model codes
- Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
- 510(k) numbers
- ["K172410"]
- PMA numbers
- not on file
- Product code
- BSP
- 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