Recalls

Resuscitator bags recalled due to defect

recalls Shutterstock 347x210 Resuscitator bags recalled due to defectSunMed Holdings LLC is recalling 18,808 units of STAT-Check and Medline resuscitator bags due to a defect that could render the device unable to deliver air to the patient, which could result in a delay in treatment and life-threatening health consequence. There have been no injuries related to this issue, to date.

STAT-Check and Medline resuscitator bags are hand-held devices commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately. In the resuscitator bags affected by the recall, the patient port retaining ring may not fully seat, which may allow the patient port to detach during use, causing the bag to not deliver air to the patient.

Health care providers with affected STAT-Check or Medline resuscitator bags have been instructed not to use them and immediately contact SunMed Holdings LLC for instructions on the return of these products. Affected units were distributed nationwide from Feb. 1, 2018, to May 13, 2018.

The recall involves the following products:

  • 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

Any adverse events or quality issues related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA Recall Notice