CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.
FDA Recall Z-1607-2011 · Posted 2011-03-08
Advertisement
Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2011-01-21
Date Terminated2013-07-09
Product Quantity31/24-cover boxes
Reason for Recall
Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.
Firm Action
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.
Root Cause
Labeling design
Distribution Pattern
Nationwide Distribution -- WA, CA, and MO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement