Knee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue
American Contract Systems Inc is recalling 36 units of its knee arthroscopy procedure kit due to excessive sterilization chemical residues in the cast padding component that exceed safe exposure 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 medical device with sterilization chemical residuals exceeding established safety limits for permanent-use devices. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems Inc is recalling 36 units of the KNEE ARTHROSCOPY-Procedure Kit (Catalog Number QPKA35A, Lot 913241) distributed nationwide in the United States.
The kit's cast padding component contains residual sterilization chemicals—ethylene oxide (EO) and ethylene chlorohydrin (ECH)—that exceed the safe exposure limits for permanent-use medical devices as specified in ANSI/AAMI/ISO 10993-7:2012 standards.
Healthcare facilities and medical professionals should be aware of this recall. The affected product is identified by UDI-DI 00191072201119 and Lot Number 913241.
The recalled product
- Product
- KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
- Manufacturer
- American Contract Systems Inc
- Affected units
- 36
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: 00191072201119 LOT#"s: 913241
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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