Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-0441-03
Recall Event ID 25118
Product Classification Gown, Surgical - Product Code FYA
Product 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***.
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
For Additional Information Contact Rodney S. Powell
360-352-9431
Manufacturer Reason
for Recall		 An indicator inside the package did not change to indicate gowns were sterilized.
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 6 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.
-
-