Summary
The FDA issued a Class II for NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile by Epimed International. Reason: Potential for stylet to protrude from the distal end of the catheter.
Details
Source
Device Recall
External ID
Z-2312-2021
Action Date
2021-08-25
Status
Completed
Category
device
Product Description
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Lot/Code Info: Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)
Quantity Affected: 132 units
Reason for Recall
Potential for stylet to protrude from the distal end of the catheter
Distribution
Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Type: Voluntary: Firm initiated
Recall Initiated: 2017-12-28
Company
Farmers Branch, TX
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 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Epimed International 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 (Epimed International) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Epimed International have FDA actions?
Epimed International 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-2312-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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