Knee Arthroscopy Kit Recalled for Elevated Sterilization Chemical Residues
American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding established safety limits.
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: FDA Class II recall for chemical residuals exceeding regulatory limits. No illnesses or injuries are reported in the source material. This qualifies as a risk-of-harm product where injury has not been reported, meeting the High severity criterion.
Plain-English summary
American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit (Catalog Number WEKA15B) distributed nationwide. The recall was issued because ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals in the cast padding component exceeded the residual limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.
The affected lot numbers are 996241 and 960241 (UDI-DI: 00191072199379). This product was distributed nationwide throughout the United States.
Ethylene oxide and ethylene chlorohydrin are sterilization byproducts. The recall addresses the concern that residual levels on these kits exceed the established safety thresholds for devices intended for permanent or prolonged contact with body tissues.
The recalled product
- Product
- KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
- Manufacturer
- American Contract Systems Inc
- Affected units
- 60
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: 00191072199379 LOT#"s: 996241 960241
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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