CLASS I Device recall · Reported 26 Aug 2015 · FDA Enforcement Report
Hudson Rci, Sheridan Sher-i Bronch Accessory Pack recalled
Teleflex Medical is recalling Hudson Rci, Sheridan Sher-i Bronch Accessory Pack, 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-2369-2015
- 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
- Masks, Gloves & PPE
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 Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
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: 5-16142, Lot numbers: 01J1300535, 01M1300215, 01A1400321, 73D1400579 and 73E1400113.
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 71360This product is part of a recall event; the main page for the event is Hudson Rci, Sheridan Sher-I-bronch, Endobronchial Tube recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hudson Rci, Sheridan Sher-I-bronch, Endobronchial Tube 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
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | 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 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 |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |