Z-3046-2017Class II

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

Name: Z-3046-2017 Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Creator: Cardinal Health 200, LLC
Published: 2017-07-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-07-28 / Terminated / root cause: packaging

FDA source

Cardinal Health 200, LLC began a recall of Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case on 2017-07-28. FDA classified it as Class II and gives the reason as "Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3046-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Posted: 2017-08-21
Terminated: 2017-12-26
Recalling firm: Medtronic, Inc.
Product: Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Product code: KKK Sudan Iv
Reason for recall: Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 200 units
Distribution: US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.
Product codes and lots: Lot number 17DAH349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3046-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3046-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21

Product code KKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)