Sterilized gowns and towels. C-Section Pack - contains 8 towels, 1 each large single-ply scrub nurse gown/towel, 2 each large gortex surgeons gown/towel, 2 each 36'' re-usable wrappers, 1 24'' re-usable wrapper. 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
- Recall Number
- Z-0441-03
- Event Number
- 25118
- Firm
- Sterile Surgical Systems Llc
- FEI Number
- 1000307344
- Product Code
- FYA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 4, 2002
- Posted
- January 14, 2003
- Terminated
- January 30, 2003
- Address
- 2757 29TH AVENUE S.W., Tumwater, WA, 98512
Description
Sterilized gowns and towels. C-Section Pack - contains 8 towels, 1 each large single-ply scrub nurse gown/towel, 2 each large gortex surgeons gown/towel, 2 each 36'' re-usable wrappers, 1 24'' re-usable wrapper. 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***.
An indicator inside the package did not change to indicate gowns were sterilized.
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.
The firm distributed to two hospitals located in the greater Seattle, WA area.
6 packs