Back in late December, 2012 GE Healthcare initiated a voluntary worldwide field correction of the T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units. Now FDA is supporting the class I recall with a further communication.
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
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.
GE Healthcare initiated the field correction on June 26, 2012, and began notifying customers with affected units through an Urgent Medical Device Correction letter and follow up has been conducted to confirm their receipt of the letter. Through these efforts, approximately 84% of identified customers have confirmed receipt of the safety instructions provided and have also confirmed all affected product has been returned or destroyed. The remaining unconfirmed customers are being contacted directly to resolve and close the issue as soon as possible. Customers have been directed to NOT use the T-piece circuit with the part numbers listed above and to isolate all affected product. To date, no patient injuries have been reported with this issue.
The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I recall, which device watchers and medical professionals probably know by now means it considers it “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”