LUNA Chest, Model No. LU4006
FDA Recall Z-0469-2015 · Posted 2014-12-01
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Recalling FirmNovadaq Technologies, Inc.
Recall StatusTerminated
Product CodeIZI
Date Initiated2014-11-04
Date Terminated2015-11-06
Product Quantity828 units
Reason for Recall
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Firm Action
Novadaq initiated their recall by telephone and followed by an email and a Medical Device Recall Notice dated November 11, 2014, to all affected customers. Distributors were instructed to notify their customers. The firm is removing the recalled products and replacing them with correctly labeled product. Customers were instructed to confirm receipt of the Recall Notice and their understanding of the actions to be taken by completing the attached confirmation form and faxing it to Novadaq Quality Department at 1-800-886-2419. For questions regarding this recall call 604-432-9861.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
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.
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