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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 04, 2002
Date Posted January 14, 2003
Recall Status1 Terminated 3 on January 30, 2003
Recall Number Z-0443-03
Recall Event ID 25118
Product Classification Gown, Surgical - Product Code FYA
Product 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***.
Code Information MFG Dates: 5/24/02, 5/28/02, 5/29/02, 5/30/02, 5/31/02, 6/3/02 
Recalling Firm/
Sterile Surgical Systems Llc
2757 29TH AVENUE S.W.
Tumwater WA 98512
For Additional Information Contact Rodney S. Powell
Manufacturer Reason
for Recall
An indicator inside the package did not change to indicate gowns were sterilized.
FDA Determined
Cause 2
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 in Commerce 98 packs
Distribution The firm distributed to two hospitals located in the greater Seattle, WA area.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.