Recall Z-1780-2018— MHC Medical Products LLC

Name: FDA recall Z-1780-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-06

Class II · Ongoing

Class II FDA medical device recall by MHC Medical Products LLC, initiated 2018-04-06. It names one FDA 510(k) clearance: K112789. Product: EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY. Reason: The retail shelf cartons may be labeled with an incorrect lot number..

Recalling firm: MHC Medical Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-04-06
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K112789 — EASY TOUCHMhc Medical Products, LLC·cleared 2011-12-23

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

EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

Reason for recall

The retail shelf cartons may be labeled with an incorrect lot number.

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