FDA Recall
Terminated
Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Sterilization occurs via EtO in Germany.
Recall: Z-0849-03
·
Initiated April 9, 2003
Recall
- Recall Number
- Z-0849-03
- Event Number
- 26213
- Firm
- Vygon Corporation
- FEI Number
- 2245270
- Product Code
- DQO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 9, 2003
- Posted
- May 20, 2003
- Terminated
- October 3, 2006
- Address
- 1 Madison Street, East Rutherford, NJ, 07073
Description
Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Sterilization occurs via EtO in Germany.
Reason
Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
Action
Recalls letters were sent out to customers and sales representatives on 4/9/2003. They were also notified via e-mails and phone calls on 4/9/2003.
Distribution
Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
Quantity
51