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Terminated

BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioPince FULL CORE BIOPSY INSTRUMENT ga. cm REF: Lot

FDA Recall Z-0952-04 · Posted 2004-07-20

Recalling FirmMedical Device Technologies, Inc.
Recall StatusTerminated
Product CodeGAA
Date Initiated2004-03-02
Date Terminated2012-07-07
Product Quantity10,303

Reason for Recall

The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.

Firm Action

The firm mailed a recall letter to accounts on 3/2/2004 asking each account to inspect their in stock product for damage and to to notify the recalling firm and return product. Also the firm enclosed a response card in a self addressed postage paid envelope.

Root Cause

Other

Distribution Pattern

The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts.

Official Source

View FDA Recall →

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

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