Procedure Tray Recalled Due to Excess Sterilization Residue
American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization 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: FDA Class II recall involving a permanent exposure device with sterilization residues exceeding safe limits per international standards. No illnesses or injuries have been reported, making this a risk-of-harm product without documented actual harm.
Plain-English summary
American Contract Systems Inc is recalling the HAND WRIST FOREARM-LF Procedure tray (Catalog Number CCHD17B). The recall involves 48 units distributed nationwide in the United States, with lot numbers 651231 and 948241.
The recalled procedure trays contain ethylene oxide and ethylene chlorohydrin residual sterilization agents at levels exceeding safe exposure limits. This is concerning because these are permanent exposure devices, meaning they remain in contact with the body. The levels exceed international biocompatibility standards (ANSI/AAMI/ISO 10993-7:2012) that govern residual sterilization agents in such devices.
Healthcare facilities and other users of this product should cease use and contact American Contract Systems Inc for information regarding return or disposal of the affected trays. The Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
- Manufacturer
- American Contract Systems Inc
- Affected units
- 48
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: 00191072193179 LOT#"s: 651231 948241
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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