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Westmed, Inc. Issues Nationwide Recall of BagEasy Manual Resuscitation Devices

Posted Sep 15 2010 12:46pm

FOR IMMEDIATE RELEASE -- September 14, 2010 - Westmed, Inc., Tucson, AZ, is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The select lots listed below of the BagEasy device 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 potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. This recall is classified by the FDA as a Class I Recall.

Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using 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

The firm voluntarily recalled the products after learning of units disconnecting at user facilities. FDA has been apprised of this action.

Westmed has become aware of a potential for disconnection at the patient port retention ring assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding units disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment.

The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers identified above.

Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products.

Consumers with questions may contact the company at 1-800-975-7987 Monday through Friday 6 AM to 5 PM Arizona Standard Time.

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.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
  • Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-FDA-0178

Photo: Product Label

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