Robotics Pack Sterilization Error Affects IV Catheter and Adhesive Components
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.
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: Class II medical device recall with potential loss of functionality and chemical residue hazards due to improper sterilization. No injuries or illnesses have been reported, fitting the rubric category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling Robotics Pack SAH units (REF SAR530M) due to improper sterilization of internal components. The affected components are the I.V. Catheter (part number 4252535-02) and Adhesive Dermabond (part number DHVM12). A total of 96 cases have been distributed in Florida and Iowa.
During an internal investigation, the company discovered that these components were inadvertently subjected to ethylene oxide sterilization at temperatures higher than those approved by the component manufacturer. As a result, the components may experience loss or lack of functionality, loss of drug efficacy (if applicable), and may contain ethylene oxide residuals higher than specified limits.
Affected customers with lot numbers 949231 or 983231 should immediately discontinue use of the product and contact American Contract Systems for replacement or further instructions. Verify the lot number and UDI (00191072179678) on your unit to determine if it is affected.
The recalled product
- Product
- Robotics Pack SAH, REF SAR530M
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 96
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 (3)
- UDI/DI00191072179678
- Lot Numbers: 949231
- 983231
Distribution
Part of a larger recall action
This product is one of 12 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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