| Class 2 Device Recall Adaptor, 040 Hum | |
Date Initiated by Firm | June 05, 2014 |
Date Posted | July 07, 2014 |
Recall Status1 |
Terminated 3 on July 02, 2015 |
Recall Number | Z-2015-2014 |
Recall Event ID |
68493 |
510(K)Number | K833974 |
Product Classification |
Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
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Product | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor. |
Code Information |
Product Code: 4000040, Lot number: AG14. |
Recalling Firm/ Manufacturer |
Teleflex Medical 4024 Stirrup Creek Dr Durham NC 27703-9000
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For Additional Information Contact | Michael T. Taggart 919-433-4829 |
Manufacturer Reason for Recall | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
FDA Determined Cause 2 | Packaging change control |
Action | Consignees were notified by letter on 06/06/2014. |
Quantity in Commerce | 7,758,650 ea. (total for all types listed) |
Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia. |
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 = BTT
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