Recall Z-0119-2019— Cypress Medical Products LLC

Name: FDA recall Z-0119-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-04

Class II · Terminated

Class II FDA medical device recall by Cypress Medical Products LLC, initiated 2018-09-04, terminated 2024-05-28. It names one FDA 510(k) clearance: K993017. Product: McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.. Reason: Small hole at the end of the syringe is impeding suction of liquid..

Recalling firm: Cypress Medical Products LLC
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Terminated: 2024-05-28
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K993017 — PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEShinchang Medical Co., Ltd.·cleared 2000-02-25

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

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

Reason for recall

Small hole at the end of the syringe is impeding suction of liquid.

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