| Class 1 Device Recall VentStar Oxylog 3000F | |
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
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Product | Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964
The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger 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
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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 Drger device/accessory contact DrgerService 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 |
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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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510(K) Database | 510(K)s with Product Code = CBK
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