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[Recalled] Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601 — Potential defect in th

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductBone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
Brand / manufacturerArgon Medical Devices, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2188-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date18 June 2015
EAN / barcode11088595

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Argon Medical Devices, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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