Hand Draping Surgical Kit Recalled for Ethylene Oxide Residue
American Contract Systems Inc is recalling the Hand Draping SJH-Procedure Kit because residual levels of ethylene oxide and ethylene chlorohydrin exceeded safe limits for permanent-contact medical 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: Ethylene oxide and ethylene chlorohydrin are toxic chemicals regulated as hazardous sterilization residues. The product is classified as a permanent-contact device with direct skin exposure, and residue levels exceeded established safety limits. Although no reported illnesses or injuries exist, the chemical hazard combined with permanent skin contact justifies a High severity rating under the risk-of-harm criterion.
Plain-English summary
American Contract Systems Inc is recalling the Hand Draping SJH-Procedure Kit (Catalog Number SJHD67F) due to excessive residual levels of ethylene oxide (EO) and ethylene chlorohydrin (ECH) in the cast padding component.
The product failed to meet residual limits specified in ANSI/AAMI/ISO 10993-7/(R)2012 standards for permanent-exposure medical devices. These chemicals are byproducts of the sterilization process and must be reduced to safe levels for devices that will remain in direct contact with patient skin.
The recall affects 352 units distributed nationwide under lot numbers 662231, 981241, 917241, and 882241 (UDI-DI: 00191072192349). Customers who have received this product should discontinue use and contact American Contract Systems Inc for instructions on return or replacement. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Surgical drape
- Affected units
- 352
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: 00191072192349 LOT#"s: 662231 981241 917241 882241
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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