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Class 2 Device Recall Drger Breathing Bag |
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Date Initiated by Firm |
March 25, 2014 |
Date Posted |
April 10, 2014 |
Recall Status1 |
Terminated 3 on October 08, 2014 |
Recall Number |
Z-1452-2014 |
Recall Event ID |
67808 |
Product Classification |
Set, tubing and support, ventilator (w harness) - Product Code BZO
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Product |
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets.
Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out. |
Code Information |
Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542. |
Recalling Firm/ Manufacturer |
Draeger Medical, Inc. 3135 Quarry Rd Telford PA 18969-1042
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For Additional Information Contact |
Customer Support 215-721-5400
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Manufacturer Reason for Recall |
Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Dr¿ger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR.
A
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FDA Determined Cause 2 |
Labeling design |
Action |
A recall notification letter, dated March 2014, was sent to wholesale distributors and end users. |
Quantity in Commerce |
433 |
Distribution |
USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD,
MO, IA, TN, MD, WV, IL,NJ, CT, and AR. |
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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