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U.S. Department of Health and Human Services

Class 2 Device Recall INFINITY DUAL HEMO MCable Pod

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 Class 2 Device Recall INFINITY DUAL HEMO MCable Podsee related information
Date Initiated by FirmOctober 04, 2017
Create DateMarch 09, 2018
Recall Status1 Terminated 3 on June 15, 2018
Recall NumberZ-0942-2018
Recall Event ID 79209
510(K)NumberK113798 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductINFINITY DUAL HEMO MCable Pod
Code Information Have the affected revision indexes: 15 or 16 (found on the product label)
Recalling Firm/
Manufacturer		 Draegar Medical Systems, Inc.
6 Tech Dr
Andover MA 01810-2434
For Additional Information ContactDhaval R. Trivedi
978-379-8000
Manufacturer Reason
for Recall		Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionIn September of 2017 an Urgent medical Device Recall letter was issued to customers informing them of the recall and to request that inventory be checked to see if the product subject in the recall is on the premises. To do this, the customer will check the label for the revision index number which is located on the upper middle portion of label. RI number 15 and 16 are included in the recall. No other numbers are subject to recall. Affected product will receive a sleeve from the company to correct the issue. Questions or concerns can be directed to 1-800-437-2437 (Press 1, then press 32349) or contact Customer Care at 1-800-437-2437 (Press 4, then press 4 again)
Quantity in Commerce2,760
DistributionNationally
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MHX
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