Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with… recallZ-1028-2015 · Smiths Medical ASD, Inc. · initiated Dec 17, 2014
Class III Terminated All recalls posted in January 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1028-2015
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Dec 17, 2014
- Posted by the FDA
- Jan 29, 2015
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 900 units
- Product code
- JKA
- FDA submissions
- K952516
- Distribution
- US in the state of FL.
Product description
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).
Code information (models, lots, serial numbers)
Lot Number: 2782094
Other devices under the same FDA submission
34 devices cleared under K952516 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Portex 4599P-1Icu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall2 reports
- Portex 4084P-1Icu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall2 reports
- Portex 4044EG-1Icu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
- Portex 4080P-2Icu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
- Portex 4080PEIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
- Portex 4080PGIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
- Portex G1460JIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection35 reports
- Portex G1467JIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection31 reports
- Portex 4043EIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection23 reports
- Portex 4558PGIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection21 reports
- Portex 4558PEIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection15 reports
- Portex G1469JIcu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page