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Terminated

Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24

FDA Recall Z-0875-04 · Posted 2004-07-20

Recalling FirmDeltec, Inc
Recall StatusTerminated
Product CodeLJT
Date Initiated2004-03-29
Date Terminated2006-12-28

Reason for Recall

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.

Firm Action

A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.

Root Cause

Other

Distribution Pattern

The recalled products were shipped nationwide in the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEMSims Deltec, Inc. · 2000-01-27

Official Source

View FDA Recall →

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

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