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EasyPoint Needle, 25G x 5/8", REF: 82091

FDA Recall #Z-1293-2024 — Class II — February 5, 2024

Recall #Z-1293-2024 Date: February 5, 2024 Classification: Class II Status: Ongoing

Product Description

EasyPoint Needle, 25G x 5/8", REF: 82091

Reason for Recall

The needle cannula of a retractable needle may detach from the needle holder in the patient.

Recalling Firm

Retractable Technologies, Inc. — Little Elm, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

477,600

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.

Code Information

UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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