Z-2035-2008

Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014...

Name: Z-2035-2008 Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014...
Creator: Physio Control, Inc.
Published: 2008-01-29
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2008-01-29 / Terminated / root cause: labeling and UDI

FDA source

Physio Control, Inc. began a recall of 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 on 2008-01-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2035-2008
Status: Terminated
Initiated: 2008-01-29
Posted: 2008-09-16
Terminated: 2011-05-04
Recalling firm: Physio Control, Inc.
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.
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
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.
Root cause tag: labeling and UDI
FDA root 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.
Quantity in commerce: 47,274 worlwide for Defibrillator Handles and Paddles
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
Product codes and lots: 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.

Product code LDD

K895379Class IILow Energy Dc - Defibrillator (Including Paddles)Physio-Control Corp. / cleared 1990-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)