Z-0439-03

Sterile gowns and towels in packages. LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse...

Name: Z-0439-03 Sterile gowns and towels in packages. LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse...
Creator: Sterile Surgical Systems Llc
Published: 2002-06-04
License: https://open.fda.gov/license/

Sterile Surgical Systems LLC / initiated 2002-06-04 / Terminated / root cause: packaging

FDA source

Sterile Surgical Systems Llc began a recall of Sterile gowns and towels in packages. LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse gown/towel, 1 each large single-ply surgeons gown... on 2002-06-04. The reason FDA records is "An indicator inside the package did not change to indicate gowns were sterilized". 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-0439-03
Status: Terminated
Initiated: 2002-06-04
Posted: 2003-01-14
Terminated: 2003-01-30
Recalling firm: Sterile Surgical Systems LLC
Product: Sterile gowns and towels in packages. LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse gown/towel, 1 each large single-ply surgeons gown, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers. Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***''.
Product code: FYA Gown, Surgical
Reason for recall: An indicator inside the package did not change to indicate gowns were sterilized.
Root cause tag: packaging
FDA root cause: Other
Action: The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
Quantity in commerce: 103 packs
Distribution: The firm distributed to two hospitals located in the greater Seattle, WA area.
Product codes and lots: Manufacturing dates on the label: MFG Dates: 5/24/02, 5/28/02, 5/29/02, 5/30/02, 5/31/02, 6/3/02

Product code FYA

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)