Arthroscopy Kit Recalled for Excessive Sterilant Residue on Padding
American Contract Systems is recalling 27 arthroscopy procedure kits because the cast padding component contains ethylene oxide and ethylene chlorohydrin residues exceeding safe limits for permanent exposure devices.
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 Class II FDA recall with no reported illnesses or injuries. The hazard is sterilant residue (ethylene oxide and ethylene chlorohydrin) exceeding safe limits on a device designed for permanent skin exposure. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
American Contract Systems Inc is recalling the ARTHROSCOPY PACK-Procedure Kit (Catalog Number TNAR22U) due to excessive sterilant residue on the cast padding component.
The cast padding contains ethylene oxide and ethylene chlorohydrin residuals that exceed the safety limits established for permanent exposure devices according to ANSI/AAMI/ISO 10993-7:2012 standards.
The recall affects 27 units (Lot #665231, UDI-DI: 00191072199768) distributed nationwide in the United States.
Healthcare facilities and practitioners who have these kits should stop using them and contact American Contract Systems Inc for instructions on replacement or return.
The recalled product
- Product
- ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Arthroscopy
- Affected units
- 27
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: 00191072199768 LOT#"s: 665231
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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