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Terminated

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***''.

FDA Recall Z-0439-03 · Posted 2003-01-14

Recalling FirmSterile Surgical Systems Llc
Recall StatusTerminated
Product CodeFYA
Date Initiated2002-06-04
Date Terminated2003-01-30
Product Quantity103 packs

Reason for Recall

An indicator inside the package did not change to indicate gowns were sterilized.

Firm 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.

Root Cause

Other

Distribution Pattern

The firm distributed to two hospitals located in the greater Seattle, WA area.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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