CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C recalled

Klarity Medical Products is recalling Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, distributed nationwide in the US. The recall was initiated on 31 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 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

Quantity recalled111 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2881-2020
FDA event ID: 86146
Recalling firm: Klarity Medical Products, Heath, OH
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2020
FDA classified: 24 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 Jul 2020	Recall initiated by company
24 Aug 2020	Classified by FDA	+24 days
2 Sep 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.

Nationwide California Florida Massachusetts New York Pennsylvania

Questions about this recall

Why was it recalled?

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

Which lots 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

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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