Terminated

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.

FDA Recall Z-2035-2008 · Posted 2008-09-16

Recalling FirmPhysio Control, Inc.

Recall StatusTerminated

Product CodeLDD

Date Initiated2008-01-29

Date Terminated2011-05-04

Product Quantity47,274 worlwide for Defibrillator Handles and 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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K895379LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)Physio-Control Corp. · 1990-02-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.