Surgical Procedure Kit Recalled for Ethylene Oxide Residual Contamination
American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory 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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard represents a risk-of-harm product (chemical residuals exceeding standards), but the potential injury is theoretical. Per the rubric, recalls with no reported harm and theoretical hazards score at most 3.
Plain-English summary
American Contract Systems Inc is recalling the ACL PACK - 206039-Procedure Kit (Catalog Number UDAC66AA) due to elevated ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residual levels exceed the limits specified by ANSI/AAMI/ISO 10993-7:(R)2012 standards for permanent-contact medical devices.
The recalled product was distributed nationwide in the United States. The affected lot number is 896241, involving 6 units. Consumers who have received this device should contact the manufacturer or their healthcare provider for further guidance.
The recalled product
- Product
- ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
- Manufacturer
- American Contract Systems Inc
- Affected units
- 6
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: 00191072216212 LOT#"s: 896241
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.
See all 39 products in this recall →Related recalls
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