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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.

FDA Recall Z-0849-03 · Posted 2003-05-20

Recalling FirmVygon Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-04-09
Date Terminated2006-10-03
Product Quantity51

Reason for Recall

Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954112VYGON LIFEVAC MID-LINE TRAYVygon Corp. · 1996-05-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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