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U.S. Department of Health and Human Services

Class 2 Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit

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  Class 2 Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit see related information
Date Initiated by Firm July 18, 2017
Date Posted August 28, 2017
Recall Status1 Terminated 3 on April 24, 2019
Recall Number Z-3080-2017
Recall Event ID 77845
Product Classification Arterial blood sampling kit - Product Code CBT
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.
Code Information Lot Number 0001047501
Recalling Firm/
Manufacturer		 Vyaire Medical
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact Lindy Schenning, RN, BSN
872-757-0109
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 5,400 units
Distribution Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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