Recall Z-0266-2023— Allison Medical, Inc.

Name: FDA recall Z-0266-2023
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Class II · Completed

Class II FDA medical device recall by Allison Medical, Inc., initiated 2018-01-19. It names one FDA 510(k) clearance: K191531. Product: InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC. Reason: Insulin syringe retail packages incorrectly labeled as "Short Needle"..

Recalling firm: Allison Medical, Inc.
Classification: Class II
Status: Completed
Initiated: 2018-01-19
Firm location: Littleton, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K191531 — Sure-Fine Insulin SyringesShina Med Corporation·cleared 2019-09-06

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

InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC

Reason for recall

Insulin syringe retail packages incorrectly labeled as "Short Needle".

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