Reported Dec 31, 2014 · Terminated
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low…
Advanced Sterilization Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346
Is this the product you have?
- STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Lot codes and dates
99 of 99 codes
102000504122010800571020007090210200080974102000707581020007081510200070925201080046102000709401020008094920108005210217040349102000708271020004040410200060693201080075102170000081021700001310200070781102000708242170606392000809551021705051110200070782102000809501020006067910200060682102000404361020007079710200070844102170504751020006066010201050501102000606832000809962010800551020008098410200050506201080040217060618102000505081020007089410201060593102000809761020007086610217000014102170504961020004035910200050484102000707911020007079210200070890102000403651020007089110200050525102000303291020006071121701009220108006910200040379
- Amount recalled
- 19,978 units total (9,792 units in US)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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