Robotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect
American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.
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: FDA Class II recall for medical devices where functionality and drug efficacy may be compromised and ethylene oxide residuals may exceed safe levels. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric's criteria for High (3).
Plain-English summary
American Contract Systems, Inc. is recalling the Robotics Pack, REF SSRO22D (56 cases, Lot Numbers 933231 and 987231), following discovery of improper sterilization of component devices. The I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were subjected to ethylene oxide sterilization at temperatures exceeding the component manufacturer's approved specifications.
As a result, these components may have reduced or lost functionality, may lose drug efficacy, and may contain ethylene oxide residuals in excess of specified limits.
The recalled product was distributed in Florida and Iowa. Customers and healthcare facilities should identify affected inventory using Lot Numbers 933231 and 987231 (UDI/DI 00191072167705) and contact American Contract Systems, Inc. or the FDA for further guidance.
The recalled product
- Product
- Robotics Pack, REF SSRO22D
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 56
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/DI 00191072167705
- Lot Numbers: 933231
- 987231
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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