Device 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.
Z-1608-2013
Product summary
- Event
- Event 65464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550 kits (OUS)
- Official record key
device-enforcement:Z-1608-2013
Official wording
Reason: 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.
Code information: Manufacturing Lot : W18499722
Distribution pattern: Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.
Derived failure modes
-
Unknown
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.