FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
- Recall number
- Z-1028-2015
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
- Status
- Terminated
- Initiated
- 2014-12-17
- Posted
- 2015-01-29
- Terminated
- 2015-06-25
- Reason
- The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
- Root cause
- Employee error
- Action
- Smiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.
- Quantity
- 900 units
- Distribution
- US in the state of FL.
- Lot, serial or model codes
- Lot Number: 2782094
- 510(k) numbers
- ["K952516"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- 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