Z-2757-2017Class II

Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health...

Name: Z-2757-2017 Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health...
Creator: Cardinal Health 200, LLC
Published: 2017-06-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-06-27 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape... on 2017-06-27. FDA classified it as Class II and gives the reason as "Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2757-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Posted: 2017-07-07
Terminated: 2019-03-29
Recalling firm: Medtronic, Inc.
Product: Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken: 1. Inspect your inventory for the affected product code and lot number (listed on the package) 2. segregate and quarantine all on-hand product 3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded. 4. Notify any customers to whom may have distributed or forwarded product affected by this product. 5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributor - 600-635-6021 All other customers - 888-444-5401 For questions regarding this recall call 800-327-7503.
Quantity in commerce: 1591 each
Distribution: Worldwide Distribution - US (Nationwide including PR) and Canada
Product codes and lots: Lot 16LFS235, expires November 1, 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2757-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2757-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-24
Z-2758-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-24

Product code KKX

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)