Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Summary
The FDA issued a Class I for Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO by Windstone Medical Packaging, Inc.. Reason: Sterility assurance for saline included in surgical kits cannot be guaranteed..
Details
Source
Device Recall
External ID
Z-1080-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Lot/Code Info: UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582
Quantity Affected: 128 kits
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Distribution
US: FL, IL, CA OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-22
Company
Billings, MT
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1080-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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