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Recall -- Firm Press Release


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.


Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators




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:

AF1040MBLot# 102091880 each
AF1040MBPLot# 102106, 10217460 each
AF1040MBSLot# 10218960 each
AF1040MB-S5Lot# 10210540 each
AF1040MB-TLot# 101917, 10215120 each
AF1100MBLot# 10222730 each
AF1140MBLot# 102081, 1021392,250 each
AF1140MB-KLot# 102093, 10216560 each
AF1140MB-P5Lot# 10214550 each
AF1140MBP-TLot# 102096290 each
AF1140MB-TLot# 101666130 each

Ventlab AirFlow Infant Resuscitator:

AF3100MB-M1Lot# 102185360 each
AF3140MB-ILot# 10212920 each
AF3140MB-KLot# 102130, 101592, 10172930 each

Ventlab AirFlow Small Adult Resuscitator:

AF5140MBPWTD5Lot# 101806, 10216340 each
AF5140MB-TLot# 102075220 each
AFD5140MB-TLot# 101928, 102211580 each

Ventlab StatCheck Adult Resuscitator:

SC9001CLot# 101360, 101751, 101819
101948, 102090, 102164
330 each
SC9001C-CLot# 101100, 101441, 101780
380 each

Ventlab SafeSpot Infant Resuscitator:

SS3200MBLot# 100130, 100251, 100381
100432, 100656, 100791
101101, 101388
320 each
SS3200MB-2Lot# 10013170 each
SS3200MB-ILot# 101238, 101370, 101480
101820, 102009
80 each
SS3200MB-MMCLot# 100129270 each
SS3200MBP-2Lot# 10205710 each
SS3200MBP-M00Lot# 100132, 101462, 102051120 each
SS3200OBLot# 100133, 100252, 100979
101178, 101863, 101975
330 each
SS3200OB-PWLot# 100253, 10013420 each

Ventlab Premium Infant Resuscitator:

VN3100MBLot# 102032630 each
VN3100MB-2Lot# 102033270 each
VN3100MBPLot# 102046, 10218220 each
VN3100MB-PW2Lot# 10205010 each
VN3100OBLot# 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 each
BT2216Lot# 1001381,800 each
BT2216FLot# 100139378 each
BT2216KLot# 100197204 each
BT2220Lot# 100140258 each
BT2220FLot# 100141270 each
BT2416Lot# 100142210 each
BT2416FLot# 100143258 each
BT2416KLot# 100198276 each
BT2420Lot# 100144222 each
BT2420FLot# 100145276 each
BT2420FKLot# 101081282 each

Provider Enterprises SafeSpot Infant Resuscitator:

Pro-1904Lot# 100155, 100183, 100451
100497, 100655, 101577
450 each
Pro-1925Lot# 101604, 101550, 1016571,300 each

Provider Enterprises Adult Resuscitator:

Pro-5009PLot# 10221710 each

Products 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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