Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavi
Summary
The FDA issued a Class II for Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation by Atrium Medical Corporation. Reason: Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch lab.
Details
Source
Device Recall
External ID
Z-1297-2022
Action Date
2022-07-06
Status
Ongoing
Category
device
Product Description
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
Lot/Code Info: UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Quantity Affected: 56 cases (560 units / 10 units per case)
Reason for Recall
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date
Distribution
AZ IL KS LA MI NY OH OK TX VA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-21
Company
Merrimack, NH
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 clearances.
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 (Atrium Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atrium Medical Corporation have FDA actions?
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1297-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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