Recall Z-0439-03 ยท FYA Gown, Surgical
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 ** Tumwate
| Date | Jan 14, 2003 (initiated Jun 4, 2002) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.