The Recall Desk
HighFDA (Devices)·Z-2713-2016·Announced 2016-09-07

Cardinal Health Recalls Arterial Blood Gas Kits Missing Safety Clasp

Cardinal Health is recalling specific lots of 9025TRU Arterial Blood Gas Kits because they are missing a locking clasp component, posing a potential safety risk.

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: The recall is classified as FDA Class II, and the source identifies a potential safety risk associated with a missing safety component, but no specific injuries or illnesses are reported.

Plain-English summary

Cardinal Health is recalling the 9025TRU Arterial Blood Gas (ABG) Kit. The recall affects three specific lots: #884993 (16,000 units), #903136 (1,900 units), and #903137 (300 units). These kits are used to obtain arterial blood samples for pH, blood gas, electrolyte, and metabolite analysis.

The recall was initiated because the kits were identified as missing the locking clasp component. CareFusion/BD identified a potential customer or user safety risk associated with this missing component. The affected products were distributed nationwide in the United States and in Canada.

Healthcare facilities and users should check their inventory for the specific lot numbers listed above. If these lots are found, they should be removed from use and returned to the manufacturer or distributor according to standard recall procedures.

The recalled product

Product
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Manufacturer
Cardinal Health

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)

  • Three (3) total lots (lot #884993
  • lot #903136 & lot #903137).

Distribution

Distributed nationwide across the United States.