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4/7/2011 1:02 PM
Recalls
"Details of the three FDA-announced recalls "
By: Tim Erskine PRODUCT The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected. Recall # Z-1548-2011 REASON LIFEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing. VOLUME OF PRODUCT IN COMMERCE 39,180 units DISTRIBUTION Nationwide and Internationally ---------- PRODUCT Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1609-2011 CODE Software versions: F.01.00 or F.01.01 RECALLING FIRM/MANUFACTURER Philips Healthcare Inc., Andover, MA, by letter on February 7, 2011. Firm initiated recall is ongoing. REASON Software: EtCO2 and Ventilation Rate values may be labeled incorrectly. VOLUME OF PRODUCT IN COMMERCE 2,382 units DISTRIBUTION Nationwide and Internationally ---------- PRODUCT 1) KING LT-D, SIZE 3, QUANTITY 1 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Recall # Z-1705-2011; 2) KING LTD, SIZE 4, QUANTITY 1 EACH, Products with a Mission, Size 4: Medium adult disposable oropharyngeal airway. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0003. Recall # Z-1706-2011; 3) KING LTD, SIZE 5, QUANTITY 1 EACH, Products with a Mission, Size 5: Large adult disposable oropharyngeal airway. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0004. Recall # Z-1707-2011; 4) KING LTS-D, SIZE 3, QUANTITY 5 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0025. Recall # Z-1708-2011; 5) KING LTS-D, SIZE 4, QUANTITY 5 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0026. Recall # Z-1709-2011; 6) KING LTS-D, SIZE 5, QUANTITY 5 EACH, Products with a Mission. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code 10-0027. Recall # Z-1710-2011; 7) CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code CRQ423. Recall # Z-1711-2011; 8) CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code CRQ424. Recall # Z-1712-2011; 9) CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code CRQ425. Recall # Z-1713-2011; 10) KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD212. Recall # Z-1714-2011; 11) KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2.5, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD2125. Recall # Z-1715-2011; 12) KING SYSTEMS, A Consort Medical Company, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 3, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD213. Recall # Z-1716-2011; 13) KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 4, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD214. Recall # Z-1717-2011 14) KING SYSTEMS, A Consort Medical Company, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 5, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTD215. Recall # Z-1718-2011; 15) KING SYSTEMS, A Consort Medical Company, KLTSD413, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 3, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KTSD413. Recall # Z-1719-2011; 16) KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 4, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTSD414. Recall # Z-1720-2011; 17) KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, KIT SIZE 5, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products. Product Code KLTSD415. Recall # Z-1721-2011 RECALLING FIRM/MANUFACTURER King Systems Corp., Noblesville, IN, by letter dated January 14, 2011 and letter dated March 3, 2011. Firm initiated recall is ongoing. REASON The product may be "inadequately sterilized" and use of this product may result in "patient infection". VOLUME OF PRODUCT IN COMMERCE 577,426 total airway kits DISTRIBUTION Nationwide and Canada
website: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm250104.htm
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