HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
FDA device recall Z-1461-2024 · posted 2024-04-02 · Open, Classified
Recall details
- Recalling firm
- O&M HALYARD, INC.
- Reason for recall
- Product was mislabeled as a Surgical Cap at its dispenser level.
- Action taken
- 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 GM-RECALLNOTIFICATION@owens-minor.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FXY
- Quantity affected
- 250 cases (75,000 pieces)
- Distribution
- 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.
- Date initiated
- 2024-02-20
- Date posted
- 2024-04-02
- Location
- Mechanicsville, VA
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