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U.S. Department of Health and Human Services

Class 1 Device Recall VentStar Oxylog 3000F

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  Class 1 Device Recall VentStar Oxylog 3000F see related information
Date Initiated by Firm May 31, 2016
Date Posted August 04, 2016
Recall Status1 Terminated 3 on March 14, 2018
Recall Number Z-2215-2016
Recall Event ID 74469
510(K)Number K062267  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964

The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
Code Information Catalog Number: 5704964
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael A. Kelhart
215-660-2349
Manufacturer Reason
for Recall		 Isolated episodes of leakage at the check valve were found
FDA Determined
Cause 2		 Device Design
Action Drager sent an Urgent Medical Device Recall letter dated May 31, 2016 and Customer Reply and Order Card to all customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to inspect stock and dispose of affected products. For questions regarding this letter call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Dr¿ger device/accessory contact Dr¿gerService Technical Support at 1-800- 543-5047 (press 4 at the prompt).
Quantity in Commerce 42,922 units worldwide (US distribution 1,530)
Distribution US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.
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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL B.V.
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