Z-0380-04

Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331

Name: Z-0380-04 Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331
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 A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331 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-0380-04
Status: Terminated
Initiated: 2004-01-08
Posted: 2004-07-20
Terminated: 2012-05-15
Recalling firm: Medtronic, Inc.
Product: Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331
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: 1 case
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 Number: 33492700

Product code NAD

K990530Class IKerlix Md Antimicrobial Gauze DressingThe Kendall Company, L.P. / cleared 2000-01-31

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)