Ventlab airflow resuscitators have been recalled. There has been a national recall of failing resuscitators. The Ventlab Corp. has announced a national recall of 14,602 of its manual resuscitators because they have failed to deliver the oxygen.
"The manual resuscitators 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," Ventlab officials said in a statement. "End users who have manual resuscitators at the lot numbers listed below should stop using them and immediately contact Ventlab Corp. for further instructions on the return of these products." According to the company
The U.S. Food and Drug Administration listed the recalled 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:
AF1040MB Lot# 102091 880 each
AF1040MBP Lot# 102106, 102174 60 each
AF1040MBS Lot# 102189 60 each
AF1040MB-S5 Lot# 102105 40 each
AF1040MB-T Lot# 101917, 102151 20 each
AF1100MB Lot# 102227 30 each
AF1140MB Lot# 102081, 102139 2,250 each
AF1140MB-K Lot# 102093, 102165 60 each
AF1140MB-P5 Lot# 102145 50 each
AF1140MBP-T Lot# 102096 290 each
AF1140MB-T Lot# 101666 130 each
Ventlab AirFlow Infant Resuscitator:
AF3100MB-M1 Lot# 102185 360 each
AF3140MB-I Lot# 102129 20 each
AF3140MB-K Lot# 102130, 101592, 101729 30 each
Ventlab AirFlow Small Adult Resuscitator:
AF5140MBPWTD5 Lot# 101806, 102163 40 each
AF5140MB-T Lot# 102075 220 each
AFD5140MB-T Lot# 101928, 102211 580 each
Ventlab StatCheck Adult Resuscitator:
SC9001C Lot# 101360, 101751, 101819
101948, 102090, 102164 330 each
SC9001C-C Lot# 101100, 101441, 101780
102193 380 each
Ventlab SafeSpot Infant Resuscitator:
SS3200MB Lot# 100130, 100251, 100381
100432, 100656, 100791
101101, 101388 320 each
SS3200MB-2 Lot# 100131 70 each
SS3200MB-I Lot# 101238, 101370, 101480
101820, 102009 80 each
SS3200MB-MMC Lot# 100129 270 each
SS3200MBP-2 Lot# 102057 10 each
SS3200MBP-M00 Lot# 100132, 101462, 102051 120 each
SS3200OB Lot# 100133, 100252, 100979
101178, 101863, 101975 330 each
SS3200OB-PW Lot# 100253, 100134 20 each
Ventlab Premium Infant Resuscitator:
VN3100MB Lot# 102032 630 each
VN3100MB-2 Lot# 102033 270 each
VN3100MBP Lot# 102046, 102182 20 each
VN3100MB-PW2 Lot# 102050 10 each
VN3100OB Lot# 102150 30 each
Ventlab Premium Small Child Resuscitator:
VN4100OB Lot# 102015 80 each
Ventlab Premium Small Adult Resuscitator:
VN5000MX Lot# 102194 30 each
Ventlab RescueMed Infant Resuscitator:
BVM700 Lot# 101638 12 each
BreathTech SafeSpot Infant Resuscitator:
BT2200FK Lot# 100196 276 each
BT2216 Lot# 100138 1,800 each
BT2216F Lot# 100139 378 each
BT2216K Lot# 100197 204 each
BT2220 Lot# 100140 258 each
BT2220F Lot# 100141 270 each
BT2416 Lot# 100142 210 each
BT2416F Lot# 100143 258 each
BT2416K Lot# 100198 276 each
BT2420 Lot# 100144 222 each
BT2420F Lot# 100145 276 each
BT2420FK Lot# 101081 282 each
Provider Enterprises SafeSpot Infant Resuscitator:
Pro-1904 Lot# 100155, 100183, 100451
100497, 100655, 101577 450 each
Pro-1925 Lot# 101604, 101550, 101657 1,300 each
Provider Enterprises Adult Resuscitator:
Pro-5009P Lot# 102217 10 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 email@example.com.The recalled manual resuscitators were manufactured and distributed nationwide to hospitals, clinics and emergency medical units from March to July.
Resuscitators are designed to provide effective breathing assistance in acute situations and are used routinely in hospitals during patient transfer between departments or as a backup to ventilators and anesthesia machines.
Manual resuscitation is a form of artificial respiration that uses a breathing bag to assist patients whose lungs are not functioning properly. The breathing bag is filled with oxygen and is squeezed by hand by a doctor, nurse or respiratory therapist.
Class Action Lawyer Network is accepting cases for failed resuscitators