FDAClass IISeptember 2, 2020

Klarity Vacuum Bags recall

Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical…

Why was Klarity Vacuum Bags recalled?

Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

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?

Lots R7504-30C: 70621Y and 81008X R7504-35BC: 70415V and 71220V R7504-35C: 81008W R7644-32.5BC: 71228S RC7221-25BC: 70502Y and 70621W RC7504-17.5C: 80411A and 80802W

Product
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical…
Recalling firm
Klarity Medical Products LLC
Quantity
111 units
Distribution
Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
Recall date
September 2, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls