Z-2699-2011

LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211

Name: Z-2699-2011 LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211
Creator: Vygon Corporation
Published: 2011-04-26
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2011-04-26 / Terminated

FDA source

Vygon Corporation began a recall of LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter on 2011-04-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2699-2011
Status: Terminated
Initiated: 2011-04-26
Posted: 2011-06-29
Terminated: 2012-06-01
Recalling firm: Vygon U.S.A.
Product: LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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 root cause: Other
Action: 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 [email protected].
Quantity in commerce: 570
Distribution: Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
Product codes and lots: Lot #s: 10101, 10I01, S0792, S0860, S0864, S0882, S1024

Product code LJS

K062425Class IILifecath S Picc and Midline CatheterVygon Corp. / cleared 2006-09-15

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)