Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case

FDA Recall Z-3046-2017 · Posted None

Recall StatusTerminated
Product CodeKKK
Date Initiated2017-07-28
Date Terminated2017-12-26
Product Quantity200 units

Reason for Recall

Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.

Firm Action

Cardinal Health sent an Urgent: Product Recall letter dated July 28, 2017. Distributors are requested to notify their customers of the action. An acknowledgement form is included as part of the notification. Responses are tracked. All returned product will be quarantined. All inventory recovered from the field will be destroyed. For further questions, please call (800) 292-9332.

Root Cause

Packaging process control

Distribution Pattern

US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑