Cardiovascular Procedure Kit catalog # 76645 & 73806
Summary
The FDA issued a Class II for Cardiovascular Procedure Kit catalog # 76645 & 73806 by Terumo Cardiovascular Systems Corp. Reason: Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping..
Details
Source
Device Recall
External ID
Z-0949-2022
Action Date
2022-04-27
Status
Terminated
Category
device
Product Description
Cardiovascular Procedure Kit catalog # 76645 & 73806
Lot/Code Info: [Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Quantity Affected: 64
Reason for Recall
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Distribution
US Nationwide distribution in the states of CA and IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-03
Company
Ashland, MA
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 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Terumo Cardiovascular Systems Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Terumo Cardiovascular Systems Corp have FDA actions?
This is the only FDA action we have on record for Terumo Cardiovascular Systems Corp in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0949-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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