Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes
Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Teleflex Medical is recalling the HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided) in sizes 28 Fr., 35 Fr., 37 Fr., 39 Fr., and 41 Fr. The recall involves 188,195 total units distributed worldwide, including the United States and several international markets.
The recall was initiated because the double swivel connector on the endobronchial tube may crack or separate. These devices are intended for use in thoracic surgery, bronchospirometry, and the administration of bronchial anesthesia.
The FDA has classified this recall as Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Healthcare providers should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- Product
- HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left 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…
- Manufacturer
- Teleflex Medical
- Affected units
- 188,195
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 5-16028
- Lot numbers: 01L1300279
- 01A1400574
- 73D1400255
- 73F1400448
- 73J1400537
- 73A1500341 and 73C1500431
- Product Code: 5-16035
- Lot numbers: 01J1300471
- 01J1300472
- 01K1300050
- 01K1300073
- 01K1300578
- 01L1300382
- 01L1300383
- 01L1300557
- 01M1300073
- 01M1300312
- 01A1400226
- 01A1400432
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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