GE Healthcare recalled the T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units. The T-piece circuits affected by this recall are sold under the following part numbers and contain a red inspection stamp (those containing a blue inspections stamp are NOT affected by this recall): M1091335 Kit, Circuit, T-Piece Disposable, 10 pack; M1091316 Kit, Circuit, T-Piece Disposable, W MASK Size 0, 10 pack; and M1091365 Kit, Circuit, T-Piece Disposable, W MASK Size 1, 10 pack.
The T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units may impact patient safety. The issue occurs when the T-piece circuit is not able to achieve maximum PIP (Peak Inspiratory Pressure) of 45 +/- 5 cmHO as measured by the built-in Airway Pressure Manometer during the pre-use checkout procedure. The built-in Airway Pressure Manometer of the resuscitation system is not affected by this issue and will accurately display airway pressure. Clinicians should always use the Airway Pressure Manometer to verify Peak Inspiratory Pressure (PIP).
The affected units were manufactured from September 10, 2009, to May 10, 2012. Customers have been directed to NOT use the T-piece circuit with the part numbers listed above and to isolate all affected product.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall