Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Summary
The FDA issued a Class II for Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 by Trinity Sterile, Inc.. Reason: Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those wit.
Details
Source
Device Recall
External ID
Z-1548-2022
Action Date
2022-08-24
Status
Terminated
Category
device
Product Description
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Lot/Code Info: UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002
Quantity Affected: 5 cases (125 eaches )
Reason for Recall
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Distribution
US Nationwide distribution in the states of FL, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
Company
Salisbury, MD
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 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Trinity Sterile, Inc. has 9 FDA actions in our database, including 9 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 (Trinity Sterile, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trinity Sterile, Inc. have FDA actions?
Trinity Sterile, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1548-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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