Recall Z-0606-2013 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
GE Healthcare, LLC
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 Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company
| Date | Dec 26, 2012 (initiated Jun 26, 2012) |
| Status | Terminated |
| Reason | Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure. |
| Root cause | Nonconforming Material/Component |
| Action | 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 s |
| Quantity | 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, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM Ohmeda Medical, Apr 20, 2007 |