LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: In
FDA device recall Z-2700-2011 · posted 2011-06-29 · Terminated
Recall details
- Recalling firm
- Vygon Corporation
- Reason for recall
- Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
- Action taken
- Vygon Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributors were provided with instructions on how to handle products that were further distributed. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-,ail at customerservice@yygonus.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 600 individual units
- Distribution
- Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
- Date initiated
- 2011-04-26
- Date posted
- 2011-06-29
- Date terminated
- 2012-06-01
- Location
- Montgomeryville, PA
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFECATH S PICC AND MIDLINE CATHETER (K062425) | Vygon Corp. | 2006-09-15 |