Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Ste
Summary
The FDA issued a Class II for Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Moni by Edwards Lifesciences, LLC. Reason: There is a potential that the pressure tubing may detach from the blood sampling system.
Details
Source
Device Recall
External ID
Z-1960-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
Lot/Code Info: Lot #s: 63470654, 63505217 and 63592430
Quantity Affected: 700 units
Reason for Recall
There is a potential that the pressure tubing may detach from the blood sampling system
Distribution
US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-26
Company
Irvine, CA
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 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 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 (Edwards Lifesciences, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edwards Lifesciences, LLC have FDA actions?
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1960-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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