Arthroscopy Procedure Kit Recalled Due to Ethylene Oxide Residue
American Contract Systems Inc is recalling 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.
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: The FDA Class II classification indicates potential for serious adverse health consequences. Ethylene oxide and ethylene chlorohydrin residuals exceed safe exposure limits established for permanent implants, creating a real chemical hazard, though no illnesses or injuries are reported in the source documentation.
Plain-English summary
American Contract Systems Inc has recalled 27 units of the ARTHROSCOPY PACK-Procedure Kit (Catalog Number TNAR22V, Lot #978241). The product was distributed nationwide in the United States.
The arthroscopy procedure kit's cast padding component contains ethylene oxide and ethylene chlorohydrin residuals that exceed the established safe exposure limits for permanent implant devices under the ANSI/AAMI/ISO 10993-7 standard. These sterilization byproducts can pose chemical exposure risks.
The FDA classified this recall as Class II.
The recalled product
- Product
- ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Arthroscopy Kit
- 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: 00191072212740 LOT#"s: 978241
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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