Recall Z-1937-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1937-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-22

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-22. It names one FDA 510(k) clearance: K061275. Product: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010. Reason: It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-04-22
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K061275 — MEDLINE SYRINGES, MULTIPLEMedline Industries, Inc.·cleared 2006-07-19

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

MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010

Reason for recall

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.

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