Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 (AVID Medical, Inc.) – devices are not suitable for organ tr... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Brand
AVID Medical, Inc.
Lot Codes / Batch Numbers
Kit Code: JACK097-08, UDI : 10809160462829, Lot No: 1654185.
Products Sold
Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
AVID Medical, Inc. is recalling Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 due to Devices are not suitable for organ transplant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices are not suitable for organ transplant.
Recommended Action
Per FDA guidance
An URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/11/25 was emailed to consignees instructing them to discontinue use of all recalled kits. Consignees are to discard all unused product. End users are to contact distributors with any questions they may have; Distributors are to forward the recall notification to customers who received distributed product. Adverse events or quality problems can be reported to Owens & Minor at complaints@owens-minor.com. An updated URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/17/25 was email to consignees instructing consignees to segregate and quarantine all impacted product remaining in inventory. Consignees are to discontinue use of the 24x30 poly bag included in the affected kits and add the provided warning label to ensure the component is discarded.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026