Procedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding
American Contract Systems Inc is recalling 36 units of Hand Pack procedure kits due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding regulatory 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 device with documented chemical residue hazard in a permanent-contact application and regulatory noncompliance, but no reported illnesses or injuries. Risk-of-harm classification with theoretical exposure.
Plain-English summary
American Contract Systems Inc is recalling 36 units of the Hand Pack 297829 Procedure Kit (Catalog Number: RGHN04I, UDI-DI: 00191072203175) distributed nationwide.
The ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals in the cast padding component exceeded the regulatory limits specified in ANSI/AAMI/ISO 10993-7:2012 for devices with permanent exposure to human tissue. Ethylene oxide is used as a sterilization agent, but residual levels must remain below specified standards to ensure safety.
Affected lot numbers are 646231 and 927241. No illnesses or injuries related to this recall have been reported.
Healthcare providers and consumers with this product should contact American Contract Systems Inc for guidance on this recall.
The recalled product
- Product
- HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
- 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: 00191072203175 LOT#"s: 646231 927241
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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