Class 2 Device Recall Internal handles and electrodes for LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, AND LIFEPAK 20 Defibrillator/

• Date Initiated by Firm: January 29, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on May 04, 2011
• Recall Number: Z-2036-2008
• Recall Event ID: 46749
• Product Classification: Low-energy DC-Defibrillator - Product Code LDD
• Product: Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024.
• Code Information: Part Number 805355 - Lot Numbers: 0001, 0060, 0080, 0090, 0100, 0102, 0104, 0106, 0107, 0123, 0197, 0200, 0203, 0204, 0205, 0206, 0207, 0300, 0301, 0304, 0305, 0306, 0307, 0398, 0399, 0404, 0405, 0407, 0499, 0500, 0501, 0502, 0503, 0504, 0505, 0507, 0600, 0601, 0604, 0605, 0606, 0607, 0698, 0700, 0703, 0704, 0705, 0706, 0707, 0800, 0802, 0803, 0804, 0805, 0806, 0807, 0895, 0899, 0900, 0901, 0903, 0904, 0905, 0906, 0907, 1000, 1001, 1002, 1004, 1005, 1006, 1007, 1023, 1097, 1099, 1101, 1103, 1104, 1105, 1106, 1107, 1201, 1202, 1204, 1205, 1206, 1207, 1298, 1300, 1302, 1304, 1305, 1306, 1307, 1398, 1400, 1402, 1403, 1404, 1405, 1406, 1407, 1498, 1499, 1501, 1502, 1505, 1506, 1601, 1602, 1603, 1604, 1605, 1606, 1607, 1700, 1701, 1702, 1703, 1704, 1705, 1706, 1707, 1797, 1799, 1801, 1802, 1804, 1805, 1806, 1807, 1898, 1899, 1903, 1905, 1906, 1907, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2101, 2103, 2104, 2105, 2106, 2107, 2202, 2203, 2205, 2206, 2207, 2298, 2299, 2300, 2301, 2302, 2304, 2305, 2306, 2399, 2402, 2403, 2405, 2406, 2407, 2499, 2500, 2501, 2502, 2503, 2505, 2506, 2507, 2599, 2600, 2601, 2602, 2603, 2605, 2606, 2607, 2698, 2699, 2702, 2800, 2802, 2806, 2807, 2899, 2900, 2901, 2903, 2904, 2905, 2906, 2907, 2999, 3000, 3001, 3002, 3005, 3006, 3007, 3098, 3099, 3100, 3101, 3102, 3104, 3105, 3106, 3107, 3197, 3198, 3203, 3204, 3205, 3206, 03294, 3299, 3302, 3303, 3305, 3306, 3398, 3399, 3400, 3401, 3403, 3404, 3405, 3406, 3407, 3498, 3499, 3500, 3501, 3503, 3505, 3507, 3597, 3599, 3602, 3603, 3605, 3606, 3607, 3697, 3698, 3699, 3700, 3701, 3702, 3705, 3706, 3707, 3798, 3799, 3805, 3806, 3807, 3899, 3900, 3901, 3905, 3906, 3907, 3998, 4000, 4003, 4005, 4006, 4007, 4099, 4100, 4101, 4102, 4103, 4105, 4106, 4107, 4197, 4199, 4200, 4201, 4203, 4204, 4206, 4207, 4298, 4299, 4300, 4302, 4304, 4305, 4306, 4307, 4399, 4401, 4405, 4406, 4498, 4499, 4500, 4502, 4503, 4506, 4507, 4600, 4601, 4603, 4605, 4606, 4607, 4699, 4701, 4702, 4704, 4705, 4706, 4797, 4799, 4803, 4805, 4806, 4900, 4904, 4906, 4907, 4998, 5000, 5001, 5002, 5003, 5005, 5006, 5103, 5105, 5106, 5199, 5200, 5203, 5204, 5205, 5206, 5299, 5301.
• FEI Number: 3015876
• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: 800-442-1142
• Manufacturer Reason for Recall: Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a risk of infection. If handle discharge button is damaged during sterilization, defibrillation therapy may be prevented.
• FDA Determined Cause: Labeling design
• Action: Starting 2/5/08, Physio-Control sent letters to customers which notifies them not to use Flash Gravity Steam, 12/88 Ethylene Oxide, STERRAD 100 machine, or Gravity Steam to sterilize. The firm recommends the use of 100% EO, STERRAD 100S machine, or Prevacuum steam for sterilization. The letter also recommends that after sterilization, the handles and paddles should be examined carefully for damage. If damaged, the product should be removed from use. The firm will follow up with a revised Sterilization Guideline document and requests posting the letter in the sterilization department in the meantime. Contact technical support at 800-442-1142 if you have questions. On 7/23/08 the firm issued new sterilization guidelines that supersede all others.
• Distribution: Distributed to hospitals and medical centers. Nationwide, DOD, and international: ARGENTINA, BAHRAIN, BANGLADESH, BERMUDA, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, INDIA, IRAN, ISRAEL, JAPAN, KOREA, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, SYRIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS - US, YEMEN, ZIMBABWE
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.