Device Recall CIVCO Latex Free NeoGuard Transducer Cover 의 리콜

Recall

57759

Class 2

Z-1607-2011

2011-01-21

2011-03-08

Terminated

United States

2013-07-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97341

Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.

The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST.