Summary
The FDA issued a Class II for Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit. by AVID Medical, Inc.. Reason: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coati.
Details
Source
Device Recall
External ID
Z-1743-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
Product Description
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Lot/Code Info: Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.
Quantity Affected: 72 units
Reason for Recall
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Distribution
US Nationwide distribution in the states of IL & LA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-31
Company
Toano, VA
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 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AVID Medical, Inc. has 125 FDA actions in our database, including 125 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 (AVID Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVID Medical, Inc. have FDA actions?
AVID Medical, Inc. has 125 FDA actions in our database, including 125 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1743-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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