FDAClass INovember 7, 2012

Safe Spot Infant Resuscitator recall

Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The…

Why was Safe Spot Infant Resuscitator recalled?

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253.

Product
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The…
Recalling firm
Ventlab Corporation
Quantity
14,602 total for all units
Distribution
Nationwide Distribution including IL, OH, NY and TN.
Recall date
November 7, 2012
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls