FDA Device Recall Z-0044-2008: Becton Dickinson & Company

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2008.

Recall Res Number

Z-0044-2008

Recalling Firm / Manufacturer

Becton Dickinson & Company

FEI Number

2243072

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-09-26

Date Posted

2007-10-18

Date Terminated

2008-01-15

Product Code

FMK

Event Number

44940

Product Quantity

1,476,000 units

Product Description Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Reason for Recall Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.

Action Details Recall communication issued on or about 9/28/2007.

Distribution Pattern Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.

Code Information / Serial Numbers Catalog Number 366356 Lot numbers: 2340296, 2353789, 3007400, 3043001, 3073415, 3100407, 3198493.

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Medical Device Recall: Z-0044-2008

Recall Parameters & Description

Related Establishments / Registrations

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