Recall Z-1608-2013 ยท DYB Introducer, Catheter
Greatbatch Medical
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, c
| Date | Jun 27, 2013 (initiated May 31, 2013) |
| Status | Terminated |
| 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. |
| 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 co |
| Quantity | 550 kits (OUS) |
| Distribution | Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110051 | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT Great Batch Medical, Feb 2, 2012 |