STERIS Recalls Quick Connects for Labeling Updates
STERIS Corporation is recalling four Quick Connect products to update labeling and remove obsolete device models.
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 for a labeling update to remove obsolete models, which is a documentation issue with no reported harm, fitting the 'Low' severity criteria.
Plain-English summary
STERIS Corporation is recalling four SYSTEM 1E Quick Connect products (QLC1677E, QRC1699E, QPC1721E, and QFC1683E). The recall involves 38 units of QLC1677E and 128 units of QRC1699E. The products were distributed nationwide, including in 30 specific states.
The firm identified the need for this recall during a routine label review. The goal is to update the products to reflect the removal of obsolete device models and to combine two existing quick connects into a single product. No injuries or illnesses have been reported in connection with these products.
Consumers and healthcare facilities should stop using the affected Quick Connects and contact STERIS Corporation for instructions on how to return or replace the products.
The recalled product
- Product
- Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing…
- 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)
- LOT NUMBERS: QLC1677E: 1986157 - 2740157
- QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.
Distribution
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