Reported Jun 8, 2016 · Terminated
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in…
Ventlab LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventlab LLC · 2710 Northridge Dr NW Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
- STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published SC9001BAdult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask — Lot numbers 303320 and 303612 SC9001CAdult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask — Lot number 303400 SC9001C-CAdult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector — Lot numbers 303523 and 303791 SC8001BPediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask — Lot number 303833 - Amount recalled
- 2430
Where it was sold
Why it was recalled
Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.
This product could cause temporary or reversible health problems — stop using it.
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