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West Virginia Office of
Emergency Medical Services
350 Capitol Street
Room 425
Charleston, WV 25301

Toll Free: 1-888--747-8367
OEMS Phone: (304) 558-3956
OEMS Fax: (304) 558-8379
Trauma Phone: (304) 290-9307
Trauma Fax: (304) 558-8379

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

While the information contained in this news article was current and accurate when we posted it, it may not necessarily represent current WVOEMS policy or procedure. If you have any questions, please contact our office at 304-558-3956.

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
Confidentiality Notice:  This message, including any attachments, is for the sole use of the individual or entity named above.  The message may contain confidential health and/or legally privileged information.  If you are not the above-named recipient, you are hereby notified that any disclosure, copying, distribution, or action taken in reliance on the contents 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.
** If you did not subscribe to the FDA Recalls, Market Withdrawals and Safety Alerts subscription you may  unsubscribe  from this list.
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.

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.

 

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