HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF0

FDA device recall Z-1423-2011 · posted 2011-02-24 · Terminated

Recall details

Recalling firm

Invacare Corporation

Reason for recall

Invacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. It also may result in contact with the motor winding, resulting in a shorted winding; this condition has the potential to result in motor failure/shutdown or to cause the motor

Action taken

The firm, INVACARE Corp., sent an "URGENT PRODUCT RECALL: IOH 200 Homefill Recall" letter dated January 10, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to "immediately examine their inventory and quarantine product subject to recall. In addition, if they may have further distributed this product, please identify their customers and notify them at once of this product recall." The customers were also instructed to complete and return an enclosed response form. Note: All product is to be return to the recalling firm. If you have any questions, contact the Manager, Regulatory Affairs at (440) 329-6356.

Root cause

Other

Status

Terminated

Product code

CAW

Quantity affected

62 Compressors

Distribution

Nationwide distribution: USA including states of: FL, GA, KY, LA, MO, NC, NE, NJ and SC.

Date initiated

2011-01-11

Date posted

2011-02-24

Date terminated

2011-11-21

Location

Elyria, OH

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