Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --
FDA device recall Z-1994-2013 · posted 2013-08-21 · Terminated
Recall details
- Recalling firm
- Getinge USA Inc
- 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.
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)
- Distribution
- Worldwide Distribution - USA and the country of Canada.
- Date initiated
- 2013-08-02
- Date posted
- 2013-08-21
- Date terminated
- 2017-02-23
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMART-READ EZTEST-STEAM SCBI AND TEST PACK (K093794) | Sgm Biotech, Inc. | 2010-05-14 |