Recall Z-0015-2011 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Navilyst Medical, Inc
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multip
| Date | Oct 7, 2010 (initiated May 24, 2010) |
| Status | Terminated |
| Reason | One box containing five catheters did not complete the sterilization process prior to distribution. |
| Root cause | Employee error |
| Action | On/about 5/24/10, NMI telephoned the consignee. The recall notification package was sent by NMI to the sole consignee on 6/11/10, followed by a telephone call by NMI Quality staff. On 6/15/10, the recall notification package was sent via FedEx to the sole consignee. Subsequently the consignee was provided a return goods authorization (RGA) number for return to NMI. The letter described the product, problem and action to be taken by the consignee/customer. The consignee/customer was instructed to immediately discontinue use of and segregate recalled product; remove the affected lot from th |
| Quantity | 1 box unit (contains 5 catheters) |
| Distribution | Nationwide distribution: Ohio only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093392 | MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS Navilyst Medical, Inc., Dec 31, 2009 |