Home / Recalls / Greatbatch Medical / Z-1608-2013

Z-1608-2013 Class II Terminated

Recalled by Greatbatch Medical — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
July 3, 2013
Initiation Date
May 31, 2013
Termination Date
August 4, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
550 kits (OUS)

Product Description

Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.

Reason for Recall

Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.

Distribution Pattern

Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.

Code Information

Manufacturing Lot : W18499722

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