FDAClass IISeptember 9, 2015

KimVent* Closed Suction System for Neonates/Pediatrics recall

KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F…

Why was KimVent* Closed Suction System for Neonates/Pediatrics recalled?

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

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 Code 206 - M5076T503, M5082T501, M5091T504; Product Code 208 - M5089T506, M5096T507, M5103T509; Product Code 210 - M5091T509; Product Code 2103 - M5082T401, M5089T401, M5138T402; Product Code 8313 - M5089T508; Product Code 20083 - M5082T403, M5082T404, M5089T402, M5103T401, M5166T402

Product
KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F…
Recalling firm
Halyard Health, Inc
Quantity
N/A
Distribution
Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Recall date
September 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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