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Terminated

REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

FDA Recall Z-0898-2013 · Posted 2013-02-28

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJS
Date Initiated2012-12-13
Date Terminated2013-07-31
Product Quantity785

Reason for Recall

The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

Firm Action

Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA Nationwide Distribution including the state of PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081904PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)Medcomp · 2008-09-23

Official Source

View FDA Recall →

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

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