Robotics Pack sterilization defect may compromise component functionality and efficacy
Two medical device components in the Robotics Pack (I.V. Cath and Adhesive Dermabond) were improperly sterilized and may lose functionality or drug efficacy. Affected units distributed in Florida and Iowa.
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 of medical device components that may lose functionality or drug efficacy due to improper sterilization. No illnesses or injuries have been reported, but the potential for patient harm from device dysfunction qualifies as a risk-of-harm product under the High severity criterion.
Plain-English summary
American Contract Systems, Inc. has recalled 112 cases of the Robotics Pack (REF SJVO56B) due to improper sterilization of component parts. The affected components include the I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12).
During an internal investigation, the manufacturer identified that these components were subjected to the sterilization process with exposure to ethylene oxide gas at temperatures higher than approved by the component manufacturer. As a result, the components may have a loss or lack of functionality, loss of drug efficacy if applicable, and higher than specified ethylene oxide residuals.
The recalled product was distributed nationwide with specific distribution in Florida and Iowa. The recalled product carries UDI/DI 00191072122339 and Lot Number 965231.
The recalled product
- Product
- Robotics Pack, REF SJVO56B
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- device-dysfunction
- efficacy-loss
- eo-residual-elevation
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 (2)
- UDI/DI 00191072122339
- Lot Numbers: 965231
Distribution
Distributed nationwide across the United States.
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