GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1

FDA device recall Z-0606-2013 · posted 2012-12-26 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter, dated June 26, 2012, with a return receipt to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction. Required Action for Users: Inspect existing stock of T-piece circuits to look for the Red inspection stamp, the T-pieces with the blue stamp are acceptable for clinical use. Separate affected circuits (with Red inspection stamp) from unaffected stock (with Blue inspection stamp). Destroy affected circuits that have the Red inspection stamp. Fill out the customer acknowledgement form and fax or forward to the GE contact address on the form. Further, it is recommended that healthcare professionals continue to emphasize the recommended pre-use checkout practices, and do not use a T-piece patient circuit that does not reach the maximum PIP level of 45 +/- 5 cmH20. Clinicians should always use the built-in Airway Pressure Manometer to verify the PIP value. For questions or concerns regarding this notification, customers should call the following phone number: 1-800-345-2700.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BTL

Quantity affected

209,804 circuits

Distribution

Worldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR,

Date initiated

2012-06-26

Date posted

2012-12-26

Date terminated

2014-04-14

Location

Waukesha, WI

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