FDA Class I Recall: Medical Action Industries Inc. Pack Cath BHH, REF:… by Medical Action Industries, Inc. 306

Key facts

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 -- Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case -- and the recall number Z-2007-2026. If it matches, stop using or distributing it and contact Medical Action Industries, Inc. 306 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.

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 Medical Action Industries, Inc. 306 and the affected product is described in FDA's record as: Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case. FDA's stated reason for the recall is: 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". The recall is tracked under FDA recall number Z-2007-2026 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.

Medical Action Industries, Inc. 306’s FDA history

Argus HQ has recorded 1 total FDA action tied to Medical Action Industries, Inc. 306: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Medical Action Industries, Inc. 306 recalled Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case. FDA's record states the reason for recall as: 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". The recall is logged under FDA recall number Z-2007-2026 with a Class I classification.

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 (Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case) and recall number Z-2007-2026, then follow Medical Action Industries, Inc. 306's recall instructions.

Has Medical Action Industries, Inc. 306 had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Medical Action Industries, Inc. 306 so far. Argus ingests new FDA enforcement records daily.

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