FDAFDA · Food and drugs·Recall number Z-2368-2015
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
Published August 26, 2015 · Recall initiated: June 1, 2015
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 double swivel connector may crack or separate on the endobronchial tube.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
- Lot
- Product Code: 5-16128, Lot numbers: 73L1400012, 73K1400582, 73L1400233 and 73A1500039; Product Code: 5-16135, Lot numbers: 73B1500259, 73B1500293, 73C1500401, 73C1500426, 01K1300470, 01B1400479, 73D1400498, 73F1400096, 73H1400443, 73J1400117, 73K1400583, 73L1400094, 73A1500205, 73A1500206 and 73B1500258; Product Code: 5-16137, Lot numbers: 73B1500354, 73B1500355, 73C1500402 and 73C1500427; Product Code: 5-16139, Lot numbers: 73G1400177, 73H1400444, 73L1400095, 73A1500041 and 73A1500203; Product Code: 5-16141, Lot numbers: 01L1300156, 01A1400452, 73G1400178, 73G1400510, 73H1400009, 73K1400553 and 73B1500257.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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