FDAClass IIMarch 12, 2014

PRE1001US: Prevena Peel and Place System Kit recall

PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of…

Why was PRE1001US: Prevena Peel and Place System Kit recalled?

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

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?

Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871

Product
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of…
Recalling firm
KCI USA, INC.
Quantity
20,850 units total
Distribution
USA Nationwide Distribution
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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