American Contract Systems Special Procedure Pack convenience kit
Summary
The FDA issued a Class II for American Contract Systems Special Procedure Pack convenience kit by American Contract Systems, Inc.. Reason: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been .
Details
Source
Device Recall
External ID
Z-2520-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
American Contract Systems Special Procedure Pack convenience kit
Lot/Code Info: (1) Model No SLSP77G; UDI-DI 00191072198730; Lot 981241; Exp. Date 1/19/2025; (2) Model No EJAG58A; UDI-DI 00191072190093; Lot 982241; Exp. Date 1/18/2025.
Quantity Affected: 112
Reason for Recall
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-06
Company
Kansas City, MO
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 158 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-2520-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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