Summary
The FDA issued a Class II for EasyPoint Needle, 25G x 5/8", REF: 82091 by Retractable Technologies, Inc.. Reason: The needle cannula of a retractable needle may detach from the needle holder in the patient..
Details
Source
Device Recall
External ID
Z-1293-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
EasyPoint Needle, 25G x 5/8", REF: 82091
Lot/Code Info: UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
Quantity Affected: 477,600
Reason for Recall
The needle cannula of a retractable needle may detach from the needle holder in the patient.
Distribution
US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-05
Company
Little Elm, 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 148 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 (Retractable Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Retractable Technologies, Inc. have FDA actions?
This is the only FDA action we have on record for Retractable Technologies, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1293-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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