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Terminated

BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

FDA Recall Z-0845-2022 · Posted None

Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeBSY
Date Initiated2021-11-22
Date Terminated2023-01-31
Product Quantity20 devices (1 case)

Reason for Recall

Product was distributed with incorrect expiration date.

Firm Action

The firm sent out a Urgent Advisory Notice dated 11/22/2021 via email to consignees notifying them of recall and identifying affected lots. Consignees were informed to check their unused inventory for affected product, and to subsequently quarantine and destroy any recalled product. Additionally, consignees were provided with a Recall Acknowledgement Form that was to be completed within five business days of receipt and returned to [email protected]. Consignees that have used recalled product and have no additional units in stock are instructed to complete the Recall Acknowledgement Form indicating that they have no inventory of impacted products.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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