Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 1000
FDA device recall Z-0015-2011 · posted 2010-10-07 · Terminated
Recall details
- Recalling firm
- Navilyst Medical, Inc
- Reason for recall
- One box containing five catheters did not complete the sterilization process prior to distribution.
- Action taken
- 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 their inventory; complete and return the Reply Verification Tracking Form via fax to the QA Manager; Navilyst Medical, Inc., at 1-518-742-4414; to please call the Navilyst Medical Customer Service at 1-800-833-9973 between 8:30 a.m. and 7:00 p.m. (Eastern Standard Time) to obtain a Return Authorization (RGA) Number, and package/ship the recalled product to Navilyst Medical, Inc, Distribution Center, Attn: QA Returns, 10 Glens Falls Technical Park, Glens Falls, NY 12801. If you have any questions, call Navilyst Medical Customer Service at 1-800-833-9973. Subsequent to the initial notification letter, NMI identified that a typo was made to the lot number on the letter. NMI telephoned the consignee and sent a revised letter via fax on 6/25/10 indicating the correct lot number.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 1 box unit (contains 5 catheters)
- Distribution
- Nationwide distribution: Ohio only
- Date initiated
- 2010-05-24
- Date posted
- 2010-10-07
- Date terminated
- 2010-10-07
- Location
- Glens Falls, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS (K093392) | Navilyst Medical, Inc. | 2009-12-31 |