Recall Z-2700-2011
Vygon Corporation · initiated April 26, 2011
Product
LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter
Codes / lots: Lot #s: 10I02, S0535, S0624, S0625, S0626, S1025
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-2700-2011
- Initiated
- April 26, 2011
- Posted by FDA
- June 29, 2011
- Terminated
- June 1, 2012
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Quantity
- 600 individual units
- Distribution
- Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
- Recalling firm
- Vygon Corporation, Montgomeryville, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2699-2011 | LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product…Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which… | 04/26/2011Terminated |