Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Physio Control, Inc.
- Recall Initiated
- January 29, 2008
- Posted
- September 16, 2008
- Terminated
- May 4, 2011
- Recall Number
- Z-2035-2008
- Quantity
- 47,274 worlwide for Defibrillator Handles and Paddles
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Part Number 805249 - Lot Numbers: 0002, 0003, 0004, 0006, 0007, 0008, 0009, 0011, 0101, 0102, 0103, 0104, 0105, 0110, 0112, 0201, 0202, 0203, 0205, 0206, 0208, 0209, 0211, 0304, 0305, 0306, 0307, 0308, 0401, 0402, 0404, 0405, 0412, 0502, 0503, 0506, 0507, 0509, 0603, 0604, 9508, 9509, 9608, 9609, 9610, 9702, 9706, 9708, 9709, 9807, 9809, 9811, 9812, 9902, 9906, 9907, 9908, 9909, 9912 ; Part Number 3010901 - Lot Numbers: 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0012, 0101, 0102, 0103, 0104, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0201, 0202, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0310, 0312, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0411, 0412, 0501, 0502, 0503, 0504, 0505, 0509, 0510, 0511, 0512, 0602, 0603, 0604, 0605, 0606, 0608, 0610, 0611, 0612, 0701, 0702, 0704, 0705, 0710, 0711, 9808, 9809, 9811, 9812, 9902, 9904, 9905, 9907, 9909, 9910, 9911, 9912.
Root Cause
Labeling design
Action Taken
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.