Class 2 Device Recall Getinge Assure

• Date Initiated by Firm: August 02, 2013
• Date Posted: August 21, 2013
• Recall Status: Terminated on February 23, 2017
• Recall Number: Z-1994-2013
• Recall Event ID: 65866
• 510(K)Number: K093794
• Product Classification: Indicator, biological sterilization process - Product Code FRC
• Product: Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121C, 132C, 134C and 135C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
• Code Information: LOT SR-430 (Expiration 02/06/2014)
• FEI Number: 3004147784
• Recalling Firm/ Manufacturer: Getinge USA Inc; 1777 E Henrietta Rd; Rochester NY 14623-3133
• For Additional Information Contact: Ms. Ann G. Wheeler; 800-475-1400 Ext. 5026
• Manufacturer Reason for Recall: AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
• FDA Determined Cause: Other
• Action: GETINGE sent an DEVICE CORRECTION NOTICE letter dated July 31, 2013, and response forms were sent to customers on August 2, 2013, via Certified Mail Return Receipt Requested. The letters instruct customers to immediately discontinue use, quarantine, and destroy the affected lot. In addition, they instruct customers to: Check the appropriate box and record the quantity of affected unused product on the enclosed Correction Response Form OR If if they do not have any lots of affected unused inventory check the box indicating such. Destroy the unused product in accordance with your institution's policy and instructions for use. Record the method of destruction on the Correction Response Form. Be sure to include the Facility Name, Address, Contact Name and Phone Number. Sign, date and e-mail the form back to SR430responseform@getinge.com within 10 days or sooner of receiving this notice. Credit will be issued upon receipt of the Correction Response Form. Replacement product of unaffected lots is currently available. The warehouse shipping the affected lot is no longer being used (due to business decision, not as result of this recall). The current warehouse is maintaining the product in a controlled temperature segregated room away from any potential sterilants. If you have any questions regarding this notification please call 1-800-475-1400 ext. 5026
• Quantity in Commerce: Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)
• Distribution: Worldwide Distribution - USA and the country of Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = FRC