Teleflex Incorporated Announces Worldwide Voluntary Recall Of HUDSON RCI SHERIDAN SHER-I-BRONCH Endobronchial Tube
WAYNE, Pa.--(BUSINESS WIRE)--Teleflex Incorporated (NYSE: TFX) announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of HUDSON RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube as a Class 1 recall. FDA defines Class I recalls as, “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.”
“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.”
Teleflex is recalling the products referenced above following receipt of customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. Should this occur, the device may leak, causing a risk of respiratory distress or hypoxia that can, in some cases, lead to the need to re-intubate the patient. There have been no reports of patient injury as a result of this issue.
Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated June 1, 2015. This recall involves the retrieval of unused product in the field.
At the time of the recall, there were 78 complaints of this issue. Two-hundred thirty-three (233) lots across twelve (12) product codes are affected by this recall for a total of 188,195 units distributed to the field. See table below for affected product codes. A full list of affected lot numbers can be found in the appendix to this notification.
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PRODUCTS AFFECTED: |
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Product Codes |
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| 5-15401 | 5-16037 | 5-16128 | 5-16139 | |||||||||
| 5-16028 | 5-16039 | 5-16135 | 5-16141 | |||||||||
| 5-16035 | 5-16041 | 5-16137 | 5-16142 | |||||||||
The original recall notice can be found at Teleflex’s website:
http://www.teleflex.com/en/recall/Sheribronch%201st%20Customer%20Notification.pdf
Consumers with questions may contact the company at 1-866-246-6990; 8am to 8pm, ET, Monday through Friday.
Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
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