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Open, Classified

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

FDA Recall Z-1461-2024 · Posted 2024-04-02

Recalling FirmO&M HALYARD, INC.
Recall StatusOpen, Classified
Product CodeFXY
Date Initiated2024-02-20
Product Quantity250 cases (75,000 pieces)

Reason for Recall

Product was mislabeled as a Surgical Cap at its dispenser level.

Firm Action

Consignees were sent an URGENT: MEDICAL DEVICE FIELD ACTION notification via email, dated 2/20/24. The notification instructs consignees to immediately discontinue use of affected devices and discard. End users are to contact their distributor/sales representative with any questions they may have. Distributors are to discard any product in stock, notify their consignees that further received product, and maintain records of effectiveness. Field Action Response Forms are to be completed and returned to the firm at [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.

Official Source

View FDA Recall →

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

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