RecallDepth

Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.

Company
Arrow International Inc
Recall Initiated
July 6, 2020
Terminated
November 5, 2021
Recall Number
Z-2802-2020
Firm Location
Reading, PA

Reason for Recall

The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

Distribution

World wide distribution

Lot / Code Info

Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547

Root Cause

Incorrect or no expiration date

Action Taken

Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.

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