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Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators

By Pharmaceutical Processing | October 19, 2012

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

 

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

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 csr@ventlab.com.

 

##

SOURCE

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