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  4. SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

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

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
General Hospital & Personal Use
Reason for Announcement:
Recall Reason Description
Defective product
Company Name:
SunMed Holdings, LLC
Brand Name:
Brand Name(s)
STAT-Check, Medline
Product Description:
Product Description
Resuscitator Bags

Company Announcement

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.

The list below provides the resuscitator bag series, features, and respective lot numbers of the recalled models:

STAT-Check MANUAL RESUSCITATOR I VENTILATOR, REF SC9200MBP-1;
Lot Numbers: 313406, 313447, 313164, 313165 & 313166

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116;
Lot Numbers:313298,313516,313588,313589, 313058,313060,313125,313173,313297,
313714, 313715 & 313774

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F;
Lot Number: 313238

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, FILTER, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC;
Lot Numbers: 313444 & 313239

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P;
Lot Number: 313545

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG
RESERVOIR, PEEP VALVE, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC;
Lot Number: 313235

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG
RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5;
Lot Numbers: 313326, 313436 & 313049

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126;
Lot Numbers: 313546, 313717, 313176 & 313772

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1126C;
Lot Numbers: 313321, 313437, 313080 & 313193

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F;
Lot Numbers: 313471, 313627 & 313696

MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE
RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL;
Lot Numbers: 313363 & 313738

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP;
Lot Numbers: 313323, 313355, 313739, 313031, 313093, 313190 & 313272

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, FILTER, PEEP VALVE, C02 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC;
Lot Number: 313315

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE
RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P;
Lot Numbers: 313502 & 313741

The recalled products were distributed nationwide and can be identified by the part number, description, and lot number on the case labels, as well as a label on the individual packaging bag.

SunMed Holdings, LLC notified its distributors and these distributors have notified their customers by a direct mailing and will arrange for the return and replacement of all recalled resuscitator bags listed above.

End Users with questions may contact SunMed Holdings, LLC via telephone at 1-800-433-2797 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. End Users may also contact SunMed Holdings, LLC via e-mail at info@sun-med.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

Company Contact Information

Consumers:
1-800-433-2797
info@sun-med.com
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