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.
This recall has been terminated (originally issued May 20, 2003).
- Company
- Vygon Corporation
- Recall Initiated
- April 9, 2003
- Posted
- May 20, 2003
- Terminated
- October 3, 2006
- Recall Number
- Z-0849-03
- Quantity
- 51
- Firm Location
- East Rutherford, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
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.
Lot / Code Info
Lot #B01A48 Exp. 11/2007
Root Cause
Other
Action Taken
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.