HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
This recall is currently active, issued April 2, 2024. It was issued by O & M Halyard, Inc..
- Company
- O & M Halyard, Inc.
- Recall Initiated
- February 20, 2024
- Posted
- April 2, 2024
- Recall Number
- Z-1461-2024
- Quantity
- 250 cases (75,000 pieces)
- Firm Location
- Mechanicsville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Product was mislabeled as a Surgical Cap at its dispenser level.
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.
Lot / Code Info
Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
Root Cause
Under Investigation by firm
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.