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Terminated

PORT-A-CATH II POWER P.A.C. Low Profile" system.

FDA Recall Z-2499-2020 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeLJT
Date Initiated2020-06-11
Date Terminated2021-01-25
Product Quantity46 kits

Reason for Recall

Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.

Firm Action

Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter.

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic Distribution: AR, CT, MS,TN,TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072657POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUSSmiths Medical MD, Inc. · 2007-12-14

Official Source

View FDA Recall →

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

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