CLASS II Device recall · Reported 26 Aug 2015 · FDA Enforcement Report
Bronchial One Lumen Tube - Right recalled by Teleflex
Teleflex is recalling Bronchial One Lumen Tube - Right, distributed in 40 states. The recall was initiated on 21 Nov 2014 and the FDA has classified it as Class II.
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-2410-2015
- FDA event ID
- 71727
- Recalling firm
- Teleflex, Wayne, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2014
- FDA classified
- 19 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Nov 2014 | Recall initiated by company | |
| 19 Aug 2015 | Classified by FDA | +271 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
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Product as listed by the FDA
Bronchial One Lumen Tube - Right
Where it was distributed
AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouri
Questions about this recall
Why was it recalled?
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Which lots are affected?
Product Code 115901-000065 Batch Number 13FT06, 13IT05, 13JT08, 13KT12, 14CT11, 14DT03, 14DT24, 14ET04, 14FT04, 14FT20, 14GT10; Product Code 115901-000080 - Batch Number 13GT16, 13KT18, 13LT08, 14CT11, 14DT03, 14DT24, 14GT15, 14HT12, 14HT20, 14JT04, 14JT12, 14JT21
Where was it sold?
AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
8 other products · FDA event 71727This product is part of a recall event; the main page for the event is Carlens Bronchial Double Lumen Tube Set (Left) Sterile recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Carlens Bronchial Double Lumen Tube Set (Left) Sterile recalled | Teleflex | Other | 40 states | |
| CLASS II | Bronchial Double Lumen Tube Set (Right), Sterile recalled by Teleflex | Teleflex | Other | 40 states | |
| CLASS II | Bronchial One Lumen Tube - Left recalled by Teleflex | Teleflex | Other | 40 states | |
| CLASS II | Bronchial Double Lumen Tube Set (Left), Sterile recalled by Teleflex | Teleflex | Other | 40 states | |
| CLASS II | Tracheopart Set (Right), Sterile recalled by Teleflex | Teleflex | Other | 40 states | |
| CLASS II | Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile recalled | Teleflex | Other | 40 states | |
| CLASS II | White Bronchial Double Lumen Tube Set (Right) Sterile recalled | Teleflex | Other | 40 states | |
| CLASS II | Tracheopart Set (Left), Sterile recalled by Teleflex | Teleflex | Other | 40 states |
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|---|---|---|---|---|---|
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| Device | CLASS I | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal recalled | Teleflex | Other | Nationwide |
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