Physio Control, Inc.: Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024.

Recall number

Z-2036-2008

Recalling firm

Physio Control, Inc.

Product

Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024.

Status

Terminated

Initiated

2008-01-29

Posted

2008-09-16

Terminated

2011-05-04

Reason

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

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

not on file

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, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

LDD

Firm FEI

3015876

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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