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U.S. Department of Health and Human Services

Class 2 Device Recall Fabius Tiro

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 Class 2 Device Recall Fabius Tirosee related information
Date Initiated by FirmAugust 26, 2010
Date PostedSeptember 23, 2010
Recall Status1 Terminated 3 on August 23, 2011
Recall NumberZ-2479-2010
Recall Event ID 56676
510(K)NumberK042419 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductFabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.
Code Information catalog #8606000
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMichael Kelhart
215-660-2349
Manufacturer Reason
for Recall		potential failures to Electri-Cord Manufacturing AC power cord
FDA Determined
Cause 2		Other
ActionDraeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: kathy.benedetto@draeger.com. 4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed. NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266. If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).
Quantity in Commerceup to 1973 products (GS & Tiro)
DistributionWorldwide Distribution: USA and countries of Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela
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 = BSZ
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