The Recall Desk
HighFDA (Devices)·Z-0141-2024·Announced 2023-11-01

Smiths Medical Blood Sampling Kits Missing Critical Filter Component

Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard—potential for erroneous test results and exposure to infectious blood—qualifies as a risk-of-harm product where injury has not yet been reported, placing it in the High category per the rubric.

Plain-English summary

Smiths Medical ASD Inc. is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits with Dry Lithium Heparin (REF 4599P-1, Lot 4331283). The kits are missing the "ASM Filter-Pro ABG SYR CAP" component from their packaging.

Without the filter cap in place, tubes have the potential to generate delayed or erroneous test results and/or exposure to infectious blood. The recall affects kits distributed in the United States.

The recalled product

Product
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device
Hazard
  • erroneous-test-results
  • infectious-blood-exposure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 30351688028635
  • Lot Number 4331283

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category