Steris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error
Steris is recalling VERIFY SixCess 270FP Challenge Packs because the outer shipping package for one lot incorrectly identifies the lot number.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 due to a packaging labeling error (incorrect lot number on the outer shipping package) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Steris Corporation is recalling 94 boxes (20 units) of VERIFY SixCess 270FP Challenge Packs, Model LCC019, Lot #024552A. The product is used to monitor steam sterilization loads processed at 270°F using typical healthcare dynamic air removal steam sterilization cycles.
The recall was initiated because the outer shipping package for this specific lot incorrectly identifies the lot as Lot #024522A. This is a labeling error on the shipping package.
The affected product was distributed nationwide in the United States, including Illinois, Louisiana, Maine, Michigan, North Carolina, Ohio, Oklahoma, Virginia, Wisconsin, and West Virginia, as well as to Canada. Healthcare facilities should stop using the affected product and contact Steris Corporation for further instructions.
The recalled product
- Product
- VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam…
- Manufacturer
- Steris Corporation
- Hazard
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 (2)
- Model LCC019
- Lot #: 024552A
Distribution
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