Total Knee Pack, REF CETJ130, medical convenience kits
Summary
The FDA issued a Class III for Total Knee Pack, REF CETJ130, medical convenience kits by American Contract Systems, Inc.. Reason: Incorrect expiration date on product..
Details
Source
Device Recall
External ID
Z-1973-2023
Action Date
2023-06-21
Status
Ongoing
Category
device
Product Description
Total Knee Pack, REF CETJ130, medical convenience kits
Lot/Code Info: UDI/DI: 00191072179593; Lot Number: 967231
Quantity Affected: 36 units
Reason for Recall
Incorrect expiration date on product.
Distribution
US Distribution to the state of: MA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-17
Company
Kansas City, MO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 137 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-1973-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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