Z-0576-03

Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park...

Name: Z-0576-03 Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park...
Creator: Allegiance Healthcare Corp.
Published: 2003-01-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-01-22 / Terminated / root cause: labeling and UDI

FDA source

Allegiance Healthcare Corp. began a recall of Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20... on 2003-01-22. The reason FDA records is "The product labeled as sterile had not been through its sterilzation cycle". 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-0576-03
Status: Terminated
Initiated: 2003-01-22
Posted: 2003-02-25
Terminated: 2003-12-03
Recalling firm: Medtronic, Inc.
Product: Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
Product code: KKX--
Reason for recall: The product labeled as sterile had not been through its sterilzation cycle.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recalled by letter dated 1/22/03. The accounts were informed of the non-sterile product, requested to examine their inventories for the affected lot, to return any product found for credit and to sub-recall the product from their customers.
Quantity in commerce: 320 drapes
Distribution: New Jersey, Georgia, Washington and Florida
Product codes and lots: lot number 02LFRW95

Product code KKX--

K002419Class IISurgical DrapesAllegiance Healthcare Coporation / cleared 2000-08-15

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)