FDAClass IIAugust 21, 2019

Medline Silicone Drain 15Fr 3/16" Full Fluted PN recall

Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen…

Why was Medline Silicone Drain 15Fr 3/16" Full Fluted PN recalled?

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

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?

Lot Code: P1841839

Product
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen…
Recalling firm
Degania Silicone, Ltd.
Quantity
200
Distribution
Nationwide Distribution
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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