Recall Z-1293-2024— Retractable Technologies, Inc.

Name: FDA recall Z-1293-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-05

Class II · Ongoing

Class II FDA medical device recall by Retractable Technologies, Inc., initiated 2024-02-05. It names one FDA 510(k) clearance: K133635. Product: EasyPoint Needle, 25G x 5/8", REF: 82091. Reason: The needle cannula of a retractable needle may detach from the needle holder in the patient..

Recalling firm: Retractable Technologies, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-05
Firm location: Little Elm, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K133635 — EASYPOINT NEEDLERetractable Technologies, Inc.·cleared 2014-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.