FDA Class I Recall: Halyard VA DETROIT CATH LAB PACK kit. Model… by AVID Medical, Inc.

Key facts

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is AVID Medical, Inc. and the affected product is described in FDA's record as: Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.. FDA's stated reason for the recall is: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.. The recall is tracked under FDA recall number Z-1979-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. -- and the recall number Z-1979-2026. If it matches, stop using or distributing it and contact AVID Medical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

AVID Medical, Inc.’s FDA history

Argus HQ has recorded 14 total FDA actions tied to AVID Medical, Inc.: 0 warning letters, 14 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.

What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.) and recall number Z-1979-2026, then follow AVID Medical, Inc.'s recall instructions.

Has AVID Medical, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 14 total FDA actions tied to AVID Medical, Inc., including 14 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1979-2026.

Related enforcement actions