Recall Z-0186-2018
Physio-Control, Inc. · initiated October 27, 2017
Class I – dangerous or defective products that could cause serious health problems or death
Product
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
Codes / lots: 713609, 717912, 713904, 718033, 715008, 719323
Reason for recall
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
FDA-determined cause: Process control
Action taken
The firm Physio Control, initiated their field action on 10/27/2017 by issuing a press release. The firm followed this with a recall notice dated 10/23/2017, to the direct consignees on 11/03/2017. The letter described the product, explained the problem and provided the following instructions: Quarantine the affected lots;contact Physio-Control at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday to arrange for replacement of your unused electrodes and "Upon receipt of this notification, post a copy of the enclosed Correct Electrode and Packaging Labeling with each of your AEDs, which shows the correct placement of the electrodes." Physio_Control will provide replacement products for all unused affected Electrodes. Should you have any questions about this Product Recall, please contact us at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday Friday.
Details
- Recall number
- Z-0186-2018
- Initiated
- October 27, 2017
- Posted by FDA
- December 12, 2017
- Terminated
- June 12, 2019
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 14,219 units in total
- Distribution
- Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa…
- Recalling firm
- Physio-Control, Inc., Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0187-2018 Class I | LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The…The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type… | 10/27/2017Terminated |