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 Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Recall
- Recall Number
- Z-0015-2011
- Event Number
- 56219
- Firm
- Navilyst Medical, Inc
- FEI Number
- 3017892510
- Product Code
- FGE
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- May 24, 2010
- Posted
- October 7, 2010
- Terminated
- October 7, 2010
- Address
- 10 Glens Falls, Technical Park Glens Falls, NY, 12801
Description
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 Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
One box containing five catheters did not complete the sterilization process prior to distribution.
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.
Nationwide distribution: Ohio only
1 box unit (contains 5 catheters)