Advanced Sterilization Products Recalls STERRAD 100S and NX Cassettes
Advanced Sterilization Products is recalling STERRAD 100S and NX cassettes because a camera used to verify printing was disabled, resulting in unverified product labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling STERRAD 100S and STERRAD NX System cassettes. The recall is due to a camera used to verify printing on the cassettes being inadvertently disabled. As a result, the cassettes were shipped without verification of proper printing.
The affected products are STERRAD 100S Cassette, Batch # 12A077, with Product Code 10113. The STERRAD 100S and STERRAD NX sterilization systems are low-temperature general purpose sterilizers used to sterilize heat and moisture-sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. Each cassette model is for use only in the matching sterilizer model.
A total of 7,495 units were distributed nationwide. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare facilities should stop using the affected cassettes and contact Advanced Sterilization Products for further instructions.
The recalled product
- Product
- STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette fo
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 7,495
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code: 10113
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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See all →- HighAdvanced Sterilization Products Recalls STERRAD NX Sterilization Systems
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