GE T-Piece Resuscitation Circuits Recalled for Pressure Deficiency

Plain-English summary

GE Healthcare, LLC is recalling specific lots of GE Giraffe and Panda T-Piece Resuscitation System circuits. The affected products are labeled as T-Piece Neonatal Patient Circuit Kits, including various sizes and catalog numbers such as M1091335, M1091316, and M1091365.

The recall was initiated because the disposable T-Piece circuits are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check-out procedure. This defect may compromise the equipment's ability to provide the required pressure for pulmonary resuscitation of infants.

The recall covers 209,804 circuits distributed worldwide, including the United States and numerous international countries. The affected products were distributed to healthcare facilities. Consumers and healthcare providers should stop using the affected circuits and contact GE Healthcare for further instructions or replacement.

The recalled product

Product

GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Ci

Manufacturer

GE Healthcare, LLC

Category

Medical Device — Resuscitation Equipment

Hazard

• pressure-deficiency
• resuscitation-failure

Affected units

209,804

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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