Surgical Knee Arthroscopy Kit Recalled for Excessive Sterilization Gas Residuals
American Contract Systems Inc is recalling its KNEE ARTHROSCOPY-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent medical devices. The recall affects 28 units with lot numbers 975241 and 920241.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (surgical device with permanent exposure potential) where residuals exceed established sterilization standards, but no injuries or hospitalizations have been reported. The FDA Class II classification without documented patient harm supports a High severity rating.
Plain-English summary
American Contract Systems Inc is recalling the KNEE ARTHROSCOPY-Procedure Kit (Catalog Number SLAR14G) due to ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals that exceed acceptable limits for permanent exposure medical devices, as specified in ANSI/AAMI/ISO 10993-7/(R)2012 standards.
A total of 28 units with lot numbers 975241 and 920241 were distributed nationwide across the United States.
Users of these kits should cease use and contact American Contract Systems Inc or their distributor for instructions on replacement or return of the affected devices.
The recalled product
- Product
- KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 28
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)
- UDI-DI: 00191072198563 LOT#"s: 975241 920241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems Inc 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.
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