FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
- Recall number
- Z-3196-2018
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
- Status
- Terminated
- Initiated
- 2018-07-13
- Posted
- not on file
- Terminated
- 2018-10-19
- Reason
- The product was mislabeled with the incorrect label.
- Root cause
- Labeling Change Control
- Action
- Recall notifications dated 7/13/2018 were issued via FedEx overnight mail on 7/13/2018 explaining the reason for recall, risk to health, and instructing the customer to check their inventory for the affected lot numbers.
- Quantity
- 29,600 kits
- Distribution
- US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
- Lot, serial or model codes
- Lot numbers 3306404, 3314069, and 3318698.
- 510(k) numbers
- ["K981035"]
- PMA numbers
- not on file
- Product code
- JKA
- 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