Sterile Surgical Systems LLC
Tumwater, WA
Sterile Surgical Systems Llc appears in FDA device records in Tumwater, WA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 5
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0443-03 | Sterilized gowns and towels. MULTI-GOWN PACK: MAJOR - contains 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' 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***. | An indicator inside the package did not change to indicate gowns were sterilized. | Terminated | ||
| Z-0442-03 | Sterilized gowns and towels. MULTI-GOWN PACK: MINOR - contains - 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' 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***. | An indicator inside the package did not change to indicate gowns were sterilized. | Terminated | ||
| Z-0441-03 | 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. | Terminated | ||
| Z-0440-03 | Sterilized gowns and towels. LINEN PACK II - contains 12 towels, 1 each large gortex scrub nurse gown/towel, 1 each extra large surgeons gown/towel, 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*** | An indicator inside the package did not change to indicate gowns were sterilized. | Terminated | ||
| Z-0439-03 | 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***''. | An indicator inside the package did not change to indicate gowns were sterilized. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain