Device 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 includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
Z-3080-2017
Product summary
- Firm
- Vyaire Medical
- Event
- Event 77845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,400 units
- Official record key
device-enforcement:Z-3080-2017
Official wording
Reason: Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
Code information: Lot Number 0001047501
Distribution pattern: Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
Derived failure modes
-
Unknown
Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.