Recall Z-3080-2017 ยท CBT Arterial Blood Sampling Kit
Vyaire Medical
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 inte
| Date | Aug 28, 2017 (initiated Jul 18, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated 07/18/2017 to its consignees. The letter described the product, problem and actions to be taken. Thee consignees were directed to inspect their current inventory and remove the recalled lot. Distributors and direct consignees were instructed to complete the Customer Response Form and return to GMB-GLB-ALFieldActions and destroy the product. If you wish to obtain credit/replacement contact Vyaire Customer Support at (800) 323.9008 (option #1) Monday-Friday 8:00am CST - 5:oopm CST. Distributors were instructed to notif |
| Quantity | 5,400 units |
| Distribution | Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.