Insufflation Filter, Sterile (2021-05-21)

Starting date:

May 21, 2021

Posting date:

June 3, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75723

Last updated:
2021-06-03

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  Reason
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  Affected products

Affected Products

Insufflation Filter, Sterile

Reason

KARL STORZ was informed about potential deviations of validated parameters for ethylene oxidesterilization at sterilization provider Steril Milano. The deviations affect certain production lots of KARLSTORZ's Insufflation Filter 031122-25 and occurred between March 2018 and February 2021.

Affected products