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Recall Observatory FDA recall evidence

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

Z-2881-2020

July 31, 2020

Class II

Product summary

Firm
Klarity Medical Products LLC
Event
Event 86146
Status
Terminated
Classification
Class II
Quantity
111 units
Official record key
device-enforcement:Z-2881-2020

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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