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Class 2 Device Recall |
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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
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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/ Manufacturer |
Sterile Surgical Systems Llc 2757 29TH AVENUE S.W. Tumwater WA 98512
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For Additional Information Contact |
Rodney S. Powell 360-352-9431
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Manufacturer Reason for Recall |
An indicator inside the package did not change to indicate gowns were sterilized.
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FDA Determined Cause 2 |
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 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
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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.
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