Recall Z-0444-2016— Myco Medical Supplies Inc

Name: FDA recall Z-0444-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-06

Class II · Terminated

Class II FDA medical device recall by Myco Medical Supplies Inc, initiated 2015-11-06, terminated 2017-05-03. It names one FDA 510(k) clearance: K945225. Product: Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle. Reason: Particulates: Complaints of rubber coring from the closure of injection vials..

Recalling firm: Myco Medical Supplies Inc
Classification: Class II
Status: Terminated
Initiated: 2015-11-06
Terminated: 2017-05-03
Firm location: Cary, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K945225 — DISPOSABLE SYRINGES AND DISPOSABLE NEEDLESMyco Medical Supplies, Inc.·cleared 1995-01-26

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

Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle

Reason for recall

Particulates: Complaints of rubber coring from the closure of injection vials.

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