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Terminated

BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ

FDA Recall Z-0957-2007 · Posted 2007-06-21

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Date Initiated2007-05-17
Date Terminated2007-08-15
Product Quantity142,800 worldwide

Reason for Recall

Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).

Firm Action

Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves.

Root Cause

Other

Distribution Pattern

Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002456MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992Becton Dickinson Vacutainer Systems · 2000-11-02

Official Source

View FDA Recall →

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

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