Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Printing Verification Failure
Advanced Sterilization Products is recalling STERRAD NX cassettes because the camera used to verify printing was disabled, resulting in unverified product labels.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a documentation/verification failure (printing) with no reported injuries.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling STERRAD 100S and STERRAD NX System cassettes. The recall involves 7,550 units of STERRAD NX Cassette, Batch # 12A078, which were distributed nationwide. These cassettes contain hydrogen peroxide and are used in low-temperature sterilizers for heat and moisture-sensitive reusable medical devices.
The recall was initiated because the camera used to verify printing on the cassettes was inadvertently disabled. Consequently, the cassettes were shipped without verification of proper printing. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected cassettes and contact Advanced Sterilization Products for instructions on removal or return.
The recalled product
- Product
- STERRAD NX Cassette, Batch # 12A078. 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…
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 7,550
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: 10133
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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