RecallRadar

FDA Device recall Z-2881-2020

Klarity Vacuum Bags, Item Nos

On 2020-09-02 the FDA classified a Class II recall of Klarity Vacuum Bags, Item Nos by Klarity Medical Products, citing vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2881-2020
ClassificationClass II
Statusterminated
Initiated2020-07-31
Published2020-09-02
Last updated2026-09-13 11:55 UTC
CompanyKlarity Medical Products
DistributionUS

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.

Reason

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

Identifiers

code_info
Lots R7504-30C: 70621Y and 81008X R7504-35BC: 70415V and 71220V R7504-35C: 81008W R7644-32.5BC: 71228S RC7221-25B…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2881-2020%22

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