Device product

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

Z-2145-2018

May 24, 2018

Class II

Product summary

Firm: Sun Med, LLC
Event: Event 80201
Status: Terminated
Classification: Class II
Quantity: 76 cases
Official record key: device-enforcement:Z-2145-2018

Official wording

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.

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

Distribution pattern: IL & OH distributors

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.