Vyaire Medical Recalls AirLife Reduced Heparin Arterial Blood Samplers
Vyaire Medical is recalling specific lots of AirLife Reduced Heparin Arterial Blood Samplers because they contain incorrect sub-assemblies with larger needles, syringes, and heparin doses.
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 involves a medical device with incorrect specifications (needle size, syringe volume, and heparin dose) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling 5,400 units of AirLife Reduced Heparin Arterial Blood Samplers, Reference 9025RHTR, Lot #0001047501. The recall involves 1 mL syringes with 25G 5/8" needles, Luer Slip protective sheaths, and 3.2 IU heparin, marked as sterile and Rx Only.
The affected kits were manufactured with incorrect sub-assemblies. These kits contain a larger needle (23 Gage, 1 inch), a larger syringe (3 mL), and a larger amount of heparin (113 IU) than intended for the specific kit reference.
The products were distributed worldwide, including nationwide distribution to Florida, Oklahoma, Virginia, Michigan, Tennessee, New Mexico, Massachusetts, Missouri, Washington, and Australia. Healthcare providers and facilities should stop using the affected lots and contact Vyaire Medical for instructions on return or replacement.
The recalled product
- Product
- AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which incl
- Manufacturer
- Vyaire Medical
- Affected units
- 5,400
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 (1)
- Lot Number 0001047501
Distribution
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