Recalls

FDA recalls defective manual resuscitation devices

Nearly 25,000 units of BagEasy Manual Resuscitation Devices are being recalled by the manufacturer, Westmed, Inc., because of a defect that could render the devices inoperable and potentially result in a delay of treatment in patients. The recall is categorized by the Food and Drug Administration (FDA) as Class 1, a classification set aside for dangerous or defective products that have a strong probability of causing serious health problems or death.

The nationwide recall involves 24,348 devices distributed to medical device distribution companies as well as directly to hospitals and other treatment facilities. The lots in question have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which can result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. Consumers who have units from the recalled lots should stop using them and return the product to Westmed or their distributor. 

The recall includes the following part numbers and lot numbers:

 

Part Number

Description

Lot Number

562013

BagEasy, Adult Resuscitator, W/Mask

47952

48174

48320

48489

48718

48893

49093

49179

49353

49567

49685

562048

 

BagEasy, Adult Resuscitator, W/Peep and Mask

47772

47896

47971

47972

48319

48449

48577

48807

48892

48970

49092

49178

562133

Child BagEasy Resuscitator w/Large and Regular Mask

48321

49225

49407

562136

Adult BagEasy Resuscitator w/Mask and CO2 EasyTM

 

47728

49094

49275

562080

BagEasy, Child Resuscitator, W/Peep and Mask

48719

49144

562081

BagEasy, Child Resuscitator, W/Peep

49643

49660

562082

BagEasy, Child Resuscitator, W/Mask

48091

49274

49386

49487

562084

BagEasy, Infant Resuscitator, W/Peep and Mask

48119

48578

48733

48941

49042

49254

562086

BagEasy, Infant Resuscitator, W/Mask

47895

48071

48488

48823

562110

BagEasy, Neonatal/Infant Resuscitor, W/Mask

49486

49611

562111

BagEasy, Neonatal/Infant Resuscitator, W/Peep and Mask

48276

49273

32628

Manual Resuscitator Adult, PSS

47769

48140

48141

48428

48142

48275

48652

32629

Manual Resuscitator Pediatric, PSS

48429

Westmed is notifying its customers and distributors by certified mail and through direct contact by sales representatives and is arranging for the return of all recalled products. Customers with questions may contact the company at 1-800-975-7987 Monday through Friday from 6 a.m. until 5 p.m. Arizona Standard Time. Any adverse events with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch