Recall Z-1461-2024— O&M HALYARD, INC.
Class III · Ongoing
Class III FDA medical device recall by O&M HALYARD, INC., initiated 2024-02-20. FDA's recall record names no specific 510(k) clearance for this event. Product: HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100). Reason: Product was mislabeled as a Surgical Cap at its dispenser level..
- Recalling firm
- O&M HALYARD, INC.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2024-02-20
- Firm location
- Mechanicsville, VA, United States
Product description
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Reason for recall
Product was mislabeled as a Surgical Cap at its dispenser level.
Data sourced from openFDA. This site is unofficial and independent of the FDA.