Z-0381-04

Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730

Name: Z-0381-04 Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730
Creator: Kendall Healthcare Products Co
Published: 2004-01-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-01-08 / Terminated / root cause: packaging

FDA source

Kendall Healthcare Products Co began a recall of Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730 on 2004-01-08. The reason FDA records is "Sterility compromised due to lack of package seal integrity". 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-0381-04
Status: Terminated
Initiated: 2004-01-08
Posted: 2004-07-20
Terminated: 2012-05-15
Recalling firm: Medtronic, Inc.
Product: Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: Sterility compromised due to lack of package seal integrity
Root cause tag: packaging
FDA root cause: Other
Action: Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
Quantity in commerce: 188 cases
Distribution: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
Product codes and lots: Lot Numbers: 33462700 33462701 33462702 33462703 33472700 33472701

Product code NAD

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)