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Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to Patients
Teleflex is recalling several types of the ISO-Gard Filter S after receiving reports that the filters may split or detach from breathing systems. If the filter splits or detaches during use, the filter may not work properly or efficiently. The issue may cause a patient to receive an insufficient supply of air and for the patient’s oxygen levels to drop below safe levels (desaturation), as well as potential cross-contamination.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
Customers with questions regarding this recall should contact Teleflex customer service by telephone: 1-866-396-2111, FAX: 1-855-419-8507, or email: Recalls@teleflex.com
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