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U.S. Department of Health and Human Services

Class 1 Device Recall Halyard Kit: Pack Cath BHH 5/Cs BANNER

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 Class 1 Device Recall Halyard Kit: Pack Cath BHH 5/Cs BANNERsee related information
Date Initiated by FirmMarch 17, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2007-2026
Recall Event ID 98698
Product Classification General surgery tray - Product Code LRO
ProductMedical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Code Information UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789
FEI Number 1030451
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer Reason
for Recall		Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn April 22, 2026, Medial Action Industries, Inc. (subsidiary of Owens & Minor) issued a "Urgent: Medical Device Recall Notification Update" via E-Mail to affected consignees. The updated notification provided clarity and and additional information for the recall strategy. Initial notification was issued on March 17, 2026. Medical Action Industries asked consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product. Convenience kits can still be used once properly labeled. 2. Add warning labels to affected Medical Action kits to ensure all users are aware of the actions below and identified in the Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. 3. If your firm used the labeling template provided with the initial letter, please adhere the revised label over the existing template label. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. 3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Complete the attached Recall Response Form and return by April 30, 2026. If you have any questions, contact Reg. Affairs Manager, Kitting, Global Products, by email: GM-OMRA_RECALLS@owens-minor.com or 470-280-4277.
Quantity in Commerce2030 kits
DistributionUS distribution to state of: AZ OUS: None
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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