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Terminated

THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit

FDA Recall Z-2693-2011 · Posted 2011-06-28

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeMSD
Date Initiated2011-05-19
Date Terminated2016-10-24
Product Quantity90

Reason for Recall

Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.

Firm Action

Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K03050214.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55Medcomp · 2003-05-20

Official Source

View FDA Recall →

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

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