Recalls / —

—#158213

Product

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

FDA product code

KKK — Sudan Iv

Device class

Class 1

Medical specialty

Hematology

Affected lot / code info

Lot number 17DAH349

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

1500 S Waukegan Rd, Waukegan, Illinois 60085-6728

Distribution

Distribution pattern

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

Timeline

Recall initiated

2017-07-28

Terminated

2017-12-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #158213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.