The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0606-2013·Announced 2013-01-02

GE T-Piece Resuscitation Circuits Recalled for Pressure Deficiency

GE Healthcare is recalling T-Piece Neonatal Patient Circuit Kits because they cannot achieve maximum Peak Inspiratory Pressure during pre-use checks.

The agency’s classification

FDA (Devices): Class I

Class I is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure."

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…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Resuscitation Equipment
Hazard
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.

Lot numbers (6)

  • 7742443
  • 7785387
  • 7860461
  • 7875369
  • 7909560
  • and 8145199.

Distribution

Distributed in 47 states:

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