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U.S. Department of Health and Human Services

Class 1 Device Recall Halyard

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 Class 1 Device Recall Halyardsee related information
Date Initiated by FirmApril 30, 2026
Date PostedJuly 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2797-2026
Recall Event ID 99339
Product Classification Cardiac catheterization kit - Product Code OES
ProductHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Code Information UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
757-566-3510
Manufacturer Reason
for Recall		Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn April 30, 2026, firm notified distributors via email. Distributors were tasked with notifying their end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. They were provided with a labeling template to print warning labels which should be affixed on all affected kits and cases in inventory. The firm is also able to provide pre-printed labels if needed. Warning labels inform users to remove and discard the manifold prior to use.
Quantity in Commerce5168 kits
DistributionUS Nationwide distribution in the states of NC and TX.
Total Product Life CycleTPLC 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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