Physio Control, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Physio Control, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Physio Control, Inc. is recalling Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: due to Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If han. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026