FDAClass IIJune 20, 2018

Stat-check Manual Resuscitator / Ventilator recall

STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

Why was Stat-check Manual Resuscitator / Ventilator recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 313406, 313447, 313164, 313165 & 313166

Product
STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
Recalling firm
Sun Med, LLC
Quantity
76 cases
Distribution
IL & OH distributors
Recall date
June 20, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls