Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Summary
The FDA issued a Class II for Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-10 by Freudenberg Medical, Llc. Reason: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia.
Details
Source
Device Recall
External ID
Z-1016-2022
Action Date
2022-05-04
Status
Terminated
Category
device
Product Description
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Lot/Code Info: Lot Numbers: PD01, PD00013140 UDI: 00850004312001
Quantity Affected: 13 units (US)
Reason for Recall
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Distribution
US distribution: GA, OH Foreign distribution: Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-21
Company
Jeffersonville, IN
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 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Freudenberg Medical, Llc has 3 FDA actions in our database, including 2 recalls and 1 clearance.
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 (Freudenberg Medical, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Freudenberg Medical, Llc have FDA actions?
Freudenberg Medical, Llc has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1016-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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