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Terminated

Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.

FDA Recall Z-0161-2010 · Posted 2009-11-10

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeMSD
Date Initiated2009-09-02
Date Terminated2010-04-16
Product Quantity100 trays

Reason for Recall

mislabeled as right are actually left

Firm Action

Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971925MEDCOMP BIO-FLEX CS CATHETER (CS100)Medical Components, Inc. · 1998-02-23

Official Source

View FDA Recall →

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

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