AngioDynamics Inc.: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".

Agency Publication Date: April 7, 2016

Affected Products

Product: NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30

Product: NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

Batch/Lot No. 4925152, 4930012; Use By 2018-08

Product: NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

Batch/Lo. 4925662 Use By 2017-02

Product: NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.

Batch/Lot No. 4931728, 4933094; Use By 2017-03

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72957

Status: Resolved

Manufacturer: AngioDynamics Inc.

Manufactured In: United States

Units Affected: 4 products (136 kits; 100 kits; 8 kits; 45 kits)

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Sources: FDA iRES · Raw API Response

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Affected Products

Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30

Batch/Lot No. 4925152, 4930012; Use By 2018-08

Batch/Lo. 4925662 Use By 2017-02

Batch/Lot No. 4931728, 4933094; Use By 2017-03