Hand Procedure Kit Recalled for Excess Ethylene Oxide Residuals
American Contract Systems recalls HAND PACK-Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residuals on the cast padding component, exceeding safe permanent-contact exposure limits.
What this means for you
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 an FDA Class II recall with no reported illnesses or injuries. The hazard involves chemical residuals exceeding safe exposure limits on a permanent-contact medical device, representing a potential risk of harm where actual injury has not yet been reported.
Plain-English summary
American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (Catalog Number WEHD16B) nationwide. The recalled units include lot numbers 662231, 983241, and 934241, with a total of 135 units distributed.
The recall is due to elevated ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals in the cast padding component. These residual levels exceed the safe limits established by ANSI/AAMI/ISO 10993-7 standards for medical devices designed for permanent contact with human tissue.
Customers who have received this product should stop using it and contact American Contract Systems Inc for instructions on returning or replacing the affected kits. No injuries have been reported.
The recalled product
- Product
- HAND PACK-Procedure Kit Catalog Number: WEHD16B
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Surgical Supply
- Hazard
- ethylene-oxide
- chemical-residue
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: 00191072188632 LOT#"s: 662231 983241 934241
Distribution
Distributed nationwide across the United States.
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