SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags
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Posted:
Friday, June 1, 2018 4:33 PM
Subject: SunMed Holdings, LLC Issues a Nationwide Recall of
STAT-Check and Medline Manual Resuscitator Bags
Good Afternoon,
See below for a U.S. Food and Drug Administration notification of a
nationwide recall.
Thank you,
Carolyn Elswick,
Healthcare System Preparedness Director
West Virginia Department of Health and Human Resources
Bureau for Public Health
Center for Threat Preparedness
505 Capitol Street, Suite 200
Charleston, West Virginia 25301
(304) 558-6900, Extension 71476
carolyn.s.elswick@wv.gov
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above. The message may contain confidential health and/or
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above-named recipient, you are hereby notified that any disclosure,
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of this message is strictly prohibited. If you have received
this message in error, please notify the sender immediately and
destroy all copies of the original message.
SunMed Holdings, LLC Issues
a Nationwide Recall of STAT-Check and Medline Manual Resuscitator
Bags
On May 29, 2018, SunMed
Holdings, LLC initiated a nationwide recall of 18,808 units of
STAT-Check and Medline resuscitator bags which were distributed
between February 1, 2018 to May 13, 2018. The patient port
retaining ring of the affected bags may not fully seat which may
allow the patient port to detach during use. If this takes place,
the resuscitator bags may not deliver air to the patient and result
in a delay in treatment and life-threatening health consequences.
There have been no reported injuries to date.
End users who have STAT-Check or Medline resuscitator bags within
the lot numbers listed below should stop using them and immediately
contact SunMed Holdings, LLC for further instructions on the return
of these products.
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Subject: SunMed Holdings, LLC Issues a Nationwide Recall of
STAT-Check and Medline Manual Resuscitator Bags
Good Afternoon,
See below for a U.S. Food and Drug Administration notification
of a nationwide recall.
Thank you,
Carolyn Elswick,
Healthcare System Preparedness Director
West Virginia Department of Health and Human Resources
Bureau for Public Health
Center for Threat Preparedness
505 Capitol Street, Suite 200
Charleston, West Virginia 25301
(304) 558-6900, Extension 71476
carolyn.s.elswick@wv.gov
SunMed Holdings, LLC
Issues a Nationwide Recall of STAT-Check and Medline Manual
Resuscitator Bags
On May 29, 2018, SunMed
Holdings, LLC initiated a nationwide recall of 18,808 units of
STAT-Check and Medline resuscitator bags which were distributed
between February 1, 2018 to May 13, 2018. The patient port
retaining ring of the affected bags may not fully seat which may
allow the patient port to detach during use. If this takes place,
the resuscitator bags may not deliver air to the patient and result
in a delay in treatment and life-threatening health consequences.
There have been no reported injuries to date.
End users who have STAT-Check or Medline resuscitator bags
within the lot numbers listed below should stop using them and
immediately contact SunMed Holdings, LLC for further instructions
on the return of these products.
For additional information pertaining to this message, please go
to
https://www.fda.gov/Safety/Recalls/ucm609533.htm?utm_campaign=SunMed%20Holdings%2C%20LLC%20Issues%20a%20Nationwide%20Recall%20of%20STAT-Check%20and%20Medline%20Manual%20Resuscitator%20Bags&utm_medium=email&utm_source=Eloqua.
