Port-A-Cath Epidural Implantable Access System

• 2 recalls, same reason

  • Terminated Z-0856-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004
  • Terminated Z-0857-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004 ·on shared PMA P900052

  Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Port-A-Cath(R) Epidural Implantable Access Syst

Trade Name

Port-A-Cath(R) Epidural Implantable Access System

Generic Name

CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL

PMA Number

P900052 ↗

FDA Product Code

LNY

Device Class

Class III

Advisory Committee

General Hospital

FDA Decision

APWD Approval withdrawn

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