Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators
Date of Recall
2012-10-19Recall Details
- 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 protected].
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