FDA Medical Device Recalls (openFDA)
Sterile Surgical Systems Llc: 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***''.
- Recall number
- Z-0439-03
- 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***''.
- Status
- Terminated
- Initiated
- 2002-06-04
- Posted
- 2003-01-14
- Terminated
- 2003-01-30
- Reason
- An indicator inside the package did not change to indicate gowns were sterilized.
- 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
- 103 packs
- Distribution
- The firm distributed to two hospitals located in the greater Seattle, WA area.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 1000307344
- Firm city
- Tumwater
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28