Z-1608-2013Class II

Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch...

Name: Z-1608-2013 Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch...
Creator: Greatbatch Medical
Published: 2013-05-31
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2013-05-31 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN... on 2013-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1608-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-31
Posted: 2013-06-27
Terminated: 2014-08-04
Recalling firm: Greatbatch Medical
Product: 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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Greatbatch Medical and Cordis sent an "Urgent Field Safety Notice" dated May 31, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were instructed: 1.Read the Description of the problem section. 2. Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. 3. Review, complete, sign and return the enclosed Acknowledgement Form in accordance with the directions on the form. 4. Either return any affected product per the attached instruction, or contact your local sales representative to facilitate return of the affected product. Credit will be provided. 5. Pass on this notice to anyone in your facility that needs to be informed. 6. If any product listed above has been forwarded to another facility, contact that facility to arrange return. 7. Maintain awareness of this notice until all product listed above has been removed from the facility and returned to Cordis. 8. Maintain a copy of this notice with affected product until product is returned. We apologize for any inconvenience this communication may cause. We know that you place high value in our products and we appreciate your cooperation in this matter. Cordis and Greatbatch are committed to maintaining your confidence in the safety and quality of the products that Greatbatch manufactures and Cordis supplies. Further questions please call (763) 951-8181.
Quantity in commerce: 550 kits (OUS)
Distribution: Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.
Product codes and lots: Manufacturing Lot : W18499722

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1608-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1608-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code DYB

K110051Class IIRadialsource Transradial Access Introducer KitGreat Batch Medical / cleared 2012-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)