FDA Recalls – February

FDA Recalls - February

Company: GE Healthcare
Product: T-Piece Circuits for the Giraffe and Panda Resuscitation Systems
Recall class: Class I
Model/catalog/lot numbers: All lots manufactured between September 01, 2009 and May 01, 2012.

  • T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask: M1091335, 10 Pack
  • T-Piece Neonatal Patient Circuit Kit Disposable with Size 0 Mask: M1091316, 10 Pack
  • T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask: M1091365, 10 Pack

Manufacturing and distribution dates: The affected products were manufactured and distributed from Sept. 1, 2009, to May 1, 2012. Use: The T-Piece Resuscitation System is used for the pulmonary resuscitation of infants.
Recalling firm: GE Healthcare, LLC. 3000 N. Grandview Blvd. Waukesha, WI 53188
Reason for recall: The disposable T-piece circuits do not achieve the maximum positive inspiratory pressure (PIP) levels of 45 +/cmH2O needed for intense resuscitation. This failure to achieve the desired inspiratory pressure during ventilation may result in inadequate therapy, and the need for additional medical intervention. This product may cause serious adverse health consequences, including death. PuBlic conTacT: Customers with the device should contact (800) 3452700 or for more information.
FDA district: Baltimore District Office
FDA comments: Customers who have purchased the affected devices were notified by letter with a return receipt dated July 12, 2012. All customers should inspect their stock of T-piece circuits and destroy all circuits with a red inspection stamp. T-pieces with a blue inspection stamp are safe for use. Customers should also fill out the customer acknowledgement form included in the recall notice and fax or mail it to the address on the form.
The recall notice recommends that clinicians do not use a T-piece patient circuit that does not reach the maximum PIP level of 45 +/cmH2O and always use the built-in Airway Pressure Manometer to verify the PIP value. Healthcare processionals should also continue to emphasize the recommended preuse checkout practices.

Company: Praxair Inc.
Product: Grab ‘n Go Vantage Portable Oxygen Cylinder Units
Recall class: Class I
Date recall initiated: November 16, 2012
Catalog number: OX-MAEGNGVNTG (U.S. and Canada) WESPRX-9500 (Global)
Range of manufacturing and distribution dates: Products were manufactured and distributed from June 17, 2009, to Nov. 16, 2012.
Use: The Grab 'n Go Vantage Portable Oxygen Cylinder unit consists of an oxygen container and pressure regulator (valve). The pressure regulator (valve) is intended for medical purposes and is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure.
Recalling firm: Praxair Inc. 39 Old Ridgebury Road Danbury, CT 06817
Reason for recall: Praxair Inc. has initiated a voluntary recall of its Grab 'n Go Vantage Portable Oxygen Cylinder unit because fires may occur inside the cylinder unit causing the wall of the unit to break and release oxygen. The fires are self extinguishing and may be caused by physical impact such as dropping or knocking over the cylinder unit. If a fire occurs, users may experience burns or a lack of oxygen (hypoxia). This product may cause serious adverse health consequences, including death. PuBlic conTacT: Customers with questions can call Praxair, Inc. at (877) 772-9247, Monday through Friday from 8am-5pm EST.
FDA district: New England District Office
FDA comments: On November 26, 2012, Praxair, Inc. sent "Medical Device Correction" letters to customers and distributors describing the product, problem and actions to be taken. Customers were also reminded of the following operating instructions:

  • Store the Grab’n Go systems indoors in a safe area,
  • Never store a system in an elevated location, and
  • Handle systems safely and avoid jarring or dropping the system. Customers were also instructed to send Grab’n Go Vantage Portable Oxygen Cylinder units to Praxair, Inc. for servicing and refilling after use in accordance with their normal processes.

Company: Fisher and Paykel Healthcare Product: Reusable Breathing Circuit
Recall class: Class I
Date recall initiated: January 3, 2013
Product: Reusable Breathing Circuit
Manufacturing dates: August 2011 – October 2011
Distribution dates: April 6, 2012 – September 27, 2012
Device model: 900MR068
Lot numbers: 110810 and 111020
Use: The Fisher & Paykel Healthcare reusable breathing circuit is a nonheated breathing circuit intended for oxygen therapy delivery for adult patients.
Recalling firm: Fisher & Paykel Healthcare Limited 15365 Barranca Parkway Irvine, CA 92618
Reason for recall: The tubes used in the reusable breathing circuit have pinholes. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Usage of the defective device may result in patient death. PuBlic conTacT: Questions should be directed to Fisher & Paykel Healthcare Limited at (800) 446-3908 ext 5003, Monday through Friday from 6 a.m. to 5 p.m. PST.
FDA district: Los Angeles
FDA comments: On Nov. 19, 2012, Fisher & Paykel issued an Urgent Medical Device Recall letter to inform customers of the problem and to provide them with a Product Recall Response form. Customers should examine their inventory and destroy and discard any affected circuits in their possession. Replacement circuits will be provided to customers upon receipt of the Product Recall Response form, which indicates the quantity of replacements required.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.