CLASS I Device recall · Reported 26 Aug 2015 · FDA Enforcement Report
Hudson Rci, Sheridan Sher-I-bronch, Endobronchial Tube recalled
Teleflex Medical is recalling Hudson Rci, Sheridan Sher-I-bronch, Endobronchial Tube (Right sided), Sizes:.... and, distributed nationwide in the US. The recall was initiated on 1 Jun 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2368-2015
- FDA event ID
- 71360
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 1 Jun 2015
- FDA classified
- 19 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2015 | Recall initiated by company | |
| 19 Aug 2015 | Classified by FDA | +79 days |
| 26 Aug 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The double swivel connector may crack or separate on the endobronchial tube.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
Questions about this recall
Why was it recalled?
The double swivel connector may crack or separate on the endobronchial tube.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 71360| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hudson Rci, Sheridan Sher-i Bronch Accessory Pack recalled | Teleflex Medical | Device Malfunction | Nationwide | |
| CLASS I | Hudson Rci, Sheridan, Sher-i-swiv and Sher-i-swiv/FO Double Swivel recalled | Teleflex Medical | Device Malfunction | Nationwide | |
| CLASS I | Hudson Rci, Sheridan Sher-I-bronch, Endobronchial Tube recalled | Teleflex Medical | Device Malfunction | Nationwide |
More recalls from Teleflex Medical
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|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
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