Recall Z-2036-2008
Physio Control, Inc. · initiated January 29, 2008
Product
Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024.
Codes / lots: 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…
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.
FDA-determined 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.
Details
- Recall number
- Z-2036-2008
- Initiated
- January 29, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- May 4, 2011
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including 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…
- Recalling firm
- Physio Control, Inc., Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2035-2008 | Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12…Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or… | 01/29/2008Terminated |