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Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators

Posted Oct 19 2012 12:01pm
Lot# 102091880 eachLot# 102106, 10217460 eachLot# 10218960 eachLot# 10210540 eachLot# 101917, 10215120 eachLot# 10222730 eachLot# 102081, 1021392,250 eachLot# 102093, 10216560 eachLot# 10214550 eachLot# 102096290 eachLot# 101666130 each
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Contact:
Consumer:
1-800-593-5654

 

FOR IMMEDIATE RELEASE - October 16, 2012 - On July 11, 2012, Ventlab Corporation initiated a nationwide recall of 14,602 of its manual resuscitators. The manual resuscitators as listed below have been found to potentially deliver little to no air/oxygen through the patient valve to the patient, which could result in life threatening health consequences that include hypoxia and hypoventilation.

End Users who have manual resuscitators at the lot numbers listed below should stop using them and immediately contact Ventlab Corporation for further instructions on the return of these products.

Recalled manual resuscitators were manufactured and distributed nationwide to distributers that sold and distributed products to hospitals, clinics and EMS units from March 2012 to July 2012.

The following models have been recalled:

Ventlab AirFlow Adult Resuscitator:
 

AF1040MB
AF1040MBP
AF1040MBS
AF1040MB-S5
AF1040MB-T
AF1100MB
AF1140MB
AF1140MB-K
AF1140MB-P5
AF1140MBP-T
AF1140MB-T


Ventlab AirFlow Infant Resuscitator:
 

AF3100MB-M1Lot# 102185360 eachAF3140MB-ILot# 10212920 eachAF3140MB-KLot# 102130, 101592, 10172930 each


Ventlab AirFlow Small Adult Resuscitator:
 

AF5140MBPWTD5Lot# 101806, 10216340 eachAF5140MB-TLot# 102075220 eachAFD5140MB-TLot# 101928, 102211580 each


Ventlab StatCheck Adult Resuscitator:
 

SC9001CLot# 101360, 101751, 101819
101948, 102090, 102164330 eachSC9001C-CLot# 101100, 101441, 101780
102193380 each


Ventlab SafeSpot Infant Resuscitator:
 

SS3200MBLot# 100130, 100251, 100381
100432, 100656, 100791
101101, 101388320 eachSS3200MB-2Lot# 10013170 eachSS3200MB-ILot# 101238, 101370, 101480
101820, 10200980 eachSS3200MB-MMCLot# 100129270 eachSS3200MBP-2Lot# 10205710 eachSS3200MBP-M00Lot# 100132, 101462, 102051120 eachSS3200OBLot# 100133, 100252, 100979
101178, 101863, 101975330 eachSS3200OB-PWLot# 100253, 10013420 each


Ventlab Premium Infant Resuscitator:
 

VN3100MBLot# 102032630 eachVN3100MB-2Lot# 102033270 eachVN3100MBPLot# 102046, 10218220 eachVN3100MB-PW2Lot# 10205010 eachVN3100OBLot# 10215030 each


Ventlab Premium Small Child Resuscitator:
 

VN4100OBLot# 10201580 each


Ventlab Premium Small Adult Resuscitator:
 

VN5000MXLot# 10219430 each


Ventlab RescueMed Infant Resuscitator:
 

BVM700Lot# 10163812 each


BreathTech SafeSpot Infant Resuscitator:
 

BT2200FKLot# 100196276 eachBT2216Lot# 1001381,800 eachBT2216FLot# 100139378 eachBT2216KLot# 100197204 eachBT2220Lot# 100140258 eachBT2220FLot# 100141270 eachBT2416Lot# 100142210 eachBT2416FLot# 100143258 eachBT2416KLot# 100198276 eachBT2420Lot# 100144222 eachBT2420FLot# 100145276 eachBT2420FKLot# 101081282 each


Provider Enterprises SafeSpot Infant Resuscitator:
 

Pro-1904Lot# 100155, 100183, 100451
100497, 100655, 101577450 eachPro-1925Lot# 101604, 101550, 1016571,300 each


Provider Enterprises Adult Resuscitator:
 

Pro-5009PLot# 10221710 eachProducts can be identified by the part number, description and lot number on case labels, as well as a small white label on the individual packaging bag.

Ventlab Corporation voluntarily recalled the above listed products after becoming aware of a product incident where the nature of the complaint was that the resuscitators were delivering little or no air through the patient valve to the patient. Ventlab Corporation has notified the FDA of this action.

No injuries have been reported to-date.

Ventlab Corporation has notified its distributors and customers by e-mail notification followed by a direct mailing and is arranging for the return/replacement/rework of all recalled manual resuscitators listed above.

End Users with questions may contact the company via telephone at 1-800-593-5654 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday. Consumer may also contact the company via e-mail at csr@ventlab.com .

    
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