Z-0368-05

McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit...

Name: Z-0368-05 McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit...
Creator: Cypress Medical Products, Ltd.
Published: 2004-12-02
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2004-12-02 / Terminated / root cause: labeling and UDI

FDA source

Cypress Medical Products, Ltd. began a recall of McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson... on 2004-12-02. The reason FDA records is "The elastic bandages which are labeled sterile have a lack of assurance of sterility". 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-0368-05
Status: Terminated
Initiated: 2004-12-02
Posted: 2004-12-24
Terminated: 2005-09-21
Recalling firm: Cypress Medical Products LLC
Product: McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide
Product code: FQM Bandage, Elastic
Reason for recall: The elastic bandages which are labeled sterile have a lack of assurance of sterility.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Cypress Medical recalled the elastic bandages fro McKesson Medical-Surgical on 12/1/04 by telephone call and letter. McKesson was requested to sub-recall the product from their customers, which they did by letter dated 12/2/04.
Quantity in commerce: 17,964 units
Distribution: Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA.
Product codes and lots: Product Numbers 16-1033-2-STR, 16-1033-3-STR, 16-1033-4-STR, 16-1033-6-STR; lot numbers 3001 through 40999

Product code FQM

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)