Recall Z-0771-2023— Remington Medical, Inc.

Name: FDA recall Z-0771-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-02

Class II · Terminated

Class II FDA medical device recall by Remington Medical, Inc., initiated 2022-12-02, terminated 2026-03-16. It names one FDA 510(k) clearance: K191315. Product: Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1). Reason: The stylet is longer than specified on the label.

Recalling firm: Remington Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-12-02
Terminated: 2026-03-16
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)Remington Medical, Inc.·cleared 2019-07-12

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

Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

Reason for recall

The stylet is longer than specified on the label

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