Z-0141-2024Class II

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Name: Z-0141-2024 Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Creator: Smiths Medical ASD Inc.
Published: 2023-09-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-09-06 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 on 2023-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0141-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-10-20
Recalling firm: Abbott Medical
Product: Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 31900 devices
Distribution: US
Product codes and lots: UDI/DI 30351688028635, Lot Number 4331283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0141-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0141-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-20

Product code JKA

K952516Class IIPro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. / cleared 1995-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)