HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Recall
- Recall Number
- Z-1461-2024
- Event Number
- 94182
- Firm
- O & M HALYARD, INC.
- FEI Number
- 3014527898
- Product Code
- FXY
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- February 20, 2024
- Posted
- April 2, 2024
- Address
- 9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015
Description
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
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].
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.
250 cases (75,000 pieces)