FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
- Recall number
- Z-0141-2024
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
- Status
- Open, Classified
- Initiated
- 2023-09-06
- Posted
- 2023-10-20
- Terminated
- not on file
- Reason
- 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
- 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
- 31900 devices
- Distribution
- US
- Lot, serial or model codes
- UDI/DI 30351688028635, Lot Number 4331283
- 510(k) numbers
- ["K952516"]
- 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