Sterilized gowns and towels. MULTI-GOWN PACK: MAJOR - contains 2 operating room towels, 1 each extra large double-ply sc
FDA device recall Z-0443-03 · posted 2003-01-14 · Terminated
Recall details
- Recalling firm
- Sterile Surgical Systems Llc
- Reason for recall
- An indicator inside the package did not change to indicate gowns were sterilized.
- Action taken
- 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
- Status
- Terminated
- Product code
- FYA
- Quantity affected
- 98 packs
- Distribution
- The firm distributed to two hospitals located in the greater Seattle, WA area.
- Date initiated
- 2002-06-04
- Date posted
- 2003-01-14
- Date terminated
- 2003-01-30
- Location
- Tumwater, WA
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