FDAFDA · Food and drugs·Recall number Z-2714-2014
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.
Published October 8, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The pediatric breathing circuits can crack prior to and during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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