| Class 1 Device Recall Hudson RCI | |
Date Initiated by Firm | September 08, 2014 |
Date Posted | September 30, 2014 |
Recall Status1 |
Terminated 3 on August 16, 2016 |
Recall Number | Z-2714-2014 |
Recall Event ID |
69194 |
Product Classification |
Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
|
Product | Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only,
Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece. |
Code Information |
Product Code: 313905, Lot #02F1300085; Product Code: 353900, Lot #02D1300584; Product Code: 353901, Lot #0241300618; Product Code: 353911, Lot #02G1300296, 02G1300861, 02F1300729; Product Code: 313901, Lot #02G1300088; Product Code: 353811, Lot #02E1300090; 02E1301383 & 02E1301867; Product Code: 353911, Lot #02F1300102 & 02F1300177; Product Code: 353900, Lot #02F1302029; Product Code: 353801, Lot #02E1300623, 02FF1300098, 02H1300172, 02H1300454, 02H1301128, 02F300180, 02E1301891, 02J1300876, 02H1301838, 02J1302412 & 02B1400324; Product Code: 353901, Lot #02E1301378; Product Code: 353900, Lot #02E1301892, 02F1300100 and Product Code: 353901, Lot #02F1302047, 02F1300101 & 2G1300879. |
Recalling Firm/ Manufacturer |
Teleflex Medical 4024 Stirrup Creek Dr Durham NC 27703-9000
|
For Additional Information Contact | Jennifer E. Suh 610-378-0131 |
Manufacturer Reason for Recall | The pediatric breathing circuits can crack prior to and during use. |
FDA Determined Cause 2 | Device Design |
Action | Teleflex Medical sent an Urgent Medical Device Recall dated September 8, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, quarantine any products with the product codes and lot numbers provided in the notification, return any affected product, complete and return the enclosed Recall Acknowledgement Form and fax it to the attention of Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990. |
Quantity in Commerce | 27,176 units |
Distribution | Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire. |
Total Product Life Cycle | TPLC 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.
|
|
|
|