Recall Z-0872-2015
Invacare Corporation · initiated October 31, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Codes / lots: The following serial numbers are affected by this recall: (Also, see attachment 1) 10CSZ430001 10FSZ622001 10JSZ621110 11BSZ621620 11HSZ620426 11LSZ620172 12CSZ622081 10CSZ430002 10FSZ622002 10JSZ621111 11BSZ621621 11HSZ620427 11LSZ620173 12CSZ622082 10CSZ430003 10FSZ622003 10JSZ621112 11BSZ621622 11HSZ620428 11LSZ620174 12CSZ622083 10CSZ430004 10FSZ622004 10JSZ621113 11BSZ621623 11HSZ620429 11LSZ620175 12CSZ622084 10CSZ430005 10FSZ622005 10JSZ621114 11BSZ621624 11HSZ620430 11LSZ620176 12CSZ622085 10CSZ430006 10FSZ622006 10JSZ621115 11BSZ621625 11HSZ620431 11LSZ620177 12CSZ622086 10CSZ430007 10FSZ622007 10JSZ621116 11BSZ621626 11HSZ620432 11LSZ620178 12CSZ622087 10CSZ430008 10FSZ622008 10JSZ621117 11BSZ621627 11HSZ620433 11LSZ620179 12CSZ622088 10CSZ430009 10FSZ622009 10JSZ621118 11BSZ621628 11HSZ620434 11LSZ620180 12CSZ622089 10CSZ430010 10FSZ622010 10JSZ621119 11BSZ621629 11HSZ620435 11LSZ620181 12CSZ622090 10CSZ430011 10FSZ622011 10JSZ621120 11BSZ621630 11HSZ620436 11LSZ620182 12CSZ622091 10CSZ430012 10FSZ622012 10JSZ621121 11BSZ621631 11HSZ620437 11LSZ620183 12CSZ622092 10CSZ430013 10FSZ622013 10JSZ621122 11BSZ621632 11HSZ620438 11LSZ620184 12CSZ622093 10CSZ430014 10FSZ622014…
Reason for recall
The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
FDA-determined cause: Device Design
Action taken
The firm initiated a recall in Europe by notification to the regulatory authority on 10/31/2014. The firm will initiate a recall in the United States on 12/03/14 by distributing a customer notification letter.
Details
- Recall number
- Z-0872-2015
- Initiated
- October 31, 2014
- Posted by FDA
- December 24, 2014
- Terminated
- February 7, 2017
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 138,446 units distributed globally
- Distribution
- The product was distributed throughout the U.S. and to foreign countries, including Canada and other countries TBD. The affected product was also distributed to eight government consignees.
- Recalling firm
- Invacare Corporation, Elyria, OH