Food, drugs, devices › Teleflex, Inc.
Device recall: Bronchial Double Lumen Tube Set (Left), Sterile
FDA enforcement event 71727 is a device recall by Teleflex, Inc. of Wayne, PA, initiated 21 Nov 2014 and classified Class II, with 9 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Aug 2017. Initiation: voluntary: firm initiated. Teleflex, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teleflex, Inc., Wayne, PA.
Reason for recall
"Customer complaints reporting that the cobb connector detached from the main connector prior to use."
Distribution
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2407-2015 | Bronchial Double Lumen Tube Set (Left), Sterile | 6,991 ea. - US & 136,759 ea. - INTL | Class II | Terminated | 26 Aug 2015 |
| Z-2408-2015 | Bronchial Double Lumen Tube Set (Right), Sterile | — | Class II | Terminated | 26 Aug 2015 |
| Z-2409-2015 | Bronchial One Lumen Tube - Left | — | Class II | Terminated | 26 Aug 2015 |
| Z-2410-2015 | Bronchial One Lumen Tube - Right | — | Class II | Terminated | 26 Aug 2015 |
| Z-2411-2015 | Carlens Bronchial Double Lumen Tube Set (Left) Sterile | — | Class II | Terminated | 26 Aug 2015 |
| Z-2412-2015 | Tracheopart Set (Left), Sterile | — | Class II | Terminated | 26 Aug 2015 |
| Z-2413-2015 | Tracheopart Set (Right), Sterile | — | Class II | Terminated | 26 Aug 2015 |
| Z-2414-2015 | White Bronchial Double Lumen Tube Set (Right) Sterile | — | Class II | Terminated | 26 Aug 2015 |
| Z-2415-2015 | Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile | — | Class II | Terminated | 26 Aug 2015 |
Context
Other enforcement events for Teleflex, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Dec 2014 | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation | Device | Class II | 1 |
| 4 Dec 2014 | MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artifi | Device | Class I | 1 |
All 3 events for Teleflex, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Customer complaints reporting that the cobb connector detached from the main connector prior to use."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Aug 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.