AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2

FDA device recall Z-3080-2017 · posted 2017-08-28 · Terminated

Recall details

Recalling firm

Vyaire Medical

Reason for recall

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.

Action taken

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 notify their customers and have them respond directly to the distributor. For any additional questions and support concerning this voluntary Recall, please contact Clinical Risk Coordinator, at (224)706-6830 or Lindy.Schenning@Vyaire.com.

Root cause

Process control

Status

Terminated

Product code

CBT

Quantity affected

5,400 units

Distribution

Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.

Date initiated

2017-07-18

Date posted

2017-08-28

Date terminated

2019-04-24

Location

Vernon Hills, IL