Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Man

FDA device recall Z-1125-04 · posted 2004-07-22 · Terminated

Recall details

Recalling firm

Medex Inc

Reason for recall

The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

Action taken

Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.

Root cause

Other

Status

Terminated

Product code

BYH

Quantity affected

4,204 units

Distribution

California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.

Date initiated

2004-07-12

Date posted

2004-07-22

Date terminated

2005-02-07

Location

Dublin, OH