CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report

Cordis a Johnson & Johnson Company recalled by Greatbatch Medical

Greatbatch Medical is recalling Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. The recall was initiated on 31 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufacturing Lot : W18499722

Quantity recalled550 kits (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1608-2013
FDA event ID: 65464
Recalling firm: Greatbatch Medical, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2013
FDA classified: 27 Jun 2013
Reported: 3 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

31 May 2013	Recall initiated by company
27 Jun 2013	Classified by FDA	+27 days
3 Jul 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Questions about this recall

Why was it recalled?

Which lots are affected?

Manufacturing Lot : W18499722

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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