FDAClass IIMarch 7, 2018

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS recall

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the…

Why was 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS recalled?

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

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 codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645

Product
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the…
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
15,678
Distribution
US Nationwide Distribution
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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