Recall Z-2148-2018— Sun Med, LLC

Name: FDA recall Z-2148-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-24

Class II · Terminated

Class II FDA medical device recall by Sun Med, LLC, initiated 2018-05-24, terminated 2020-05-12. It names one FDA 510(k) clearance: K953546. Product: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC. Reason: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient..

Recalling firm: Sun Med, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Terminated: 2020-05-12
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K953546 — MANUAL PULMONARY RESUSICITATORMedical Marketing Concepts·cleared 1996-02-29

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 ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC

Reason for recall

There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.

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