Recall Z-1461-2024 ยท FXY Hood, Surgical
O&M HALYARD, INC.
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
| Date | Apr 2, 2024 (initiated Feb 20, 2024) |
| Status | Open, Classified |
| Reason | Product was mislabeled as a Surgical Cap at its dispenser level. |
| Root cause | Under Investigation by 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 GM-RECALLNOTIFICATION@owens-minor.com. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.