Summary
The FDA issued a Class II for Robotics Pack SAH, REF SAR530M by American Contract Systems, Inc.. Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12).
Details
Source
Device Recall
External ID
Z-0174-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
Robotics Pack SAH, REF SAR530M
Lot/Code Info: UDI/DI00191072179678, Lot Numbers: 949231, 983231
Quantity Affected: 96 cases
Reason for Recall
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
Distribution
US Nationwide distribution in the states of FL, IA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-01
Company
Temple Terrace, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems, Inc. have FDA actions?
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0174-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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