Z-0114-04

Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline...

Name: Z-0114-04 Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline...
Creator: Medline Industries Inc
Published: 2003-10-07
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2003-10-07 / Terminated / root cause: labeling and UDI

FDA source

Medline Industries Inc began a recall of Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486 on 2003-10-07. The reason FDA records is "The product, labeled as sterile, had not gone through the sterilization process at the time of shipment". 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-0114-04
Status: Terminated
Initiated: 2003-10-07
Posted: 2003-11-13
Terminated: 2003-11-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product.
Quantity in commerce: 44 cases
Distribution: Ohio, Iowa, Illinois, Wisconsin and Indiana
Product codes and lots: Reorder #MDT2168204, lot 03IA0532

Product code KKX

K962205Class IISterile and Non-Sterile o.r. Towels, Sterile and Non-Sterile X-Ray Detectable o.r. Towels, Single UseMedline Industries, Inc. / cleared 1996-11-26

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)