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U.S. Department of Health and Human Services

Class 3 Device Recall Surgical Hood

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  Class 3 Device Recall Surgical Hood see related information
Date Initiated by Firm February 20, 2024
Date Posted April 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-1461-2024
Recall Event ID 94182
Product Classification Hood, surgical - Product Code FXY
Product HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Code Information Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
Recalling Firm/
Manufacturer		 O&M HALYARD, INC.
9120 Lockwood Blvd
Mechanicsville VA 23116-2015
For Additional Information Contact Lola Valle
470-552-1703
Manufacturer Reason
for Recall		 Product was mislabeled as a Surgical Cap at its dispenser level.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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