Portex recallZ-0141-2024 · Smiths Medical ASD Inc. · initiated Sep 6, 2023
Open, Classified
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 complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
FDA root cause category: Process control
What the company is doing
Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/06/2023 by mail. The notice explained the problem with the device, potential risk, and requested the following: 1. Discontinue use, distribution, and quarantine all affected product in inventory. 2. Notify all potential users within the consignee organization 3. Distributors were directed to notify their customers. Questions: Customer Service 1-(800)-258-5361
Recall details
- Recall number
- Z-0141-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 6, 2023
- Posted by the FDA
- Oct 20, 2023
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 31900 devices
- Product code
- JKA
- FDA submissions
- K952516
- Distribution
- US
Product description
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Code information (models, lots, serial numbers)
UDI/DI 30351688028635, Lot Number 4331283
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Portex 4599P-1Icu Medical, Inc. · Tubes, vials, systems, serum separators, blood collection1 recall2 reports
Product lines
Other devices under the same FDA submission
33 devices cleared under K952516 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 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
- Portex 4042EIcu 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 16, 2026. Text above is shown as published by the FDA.
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