FDA Recall Terminated

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.

Recall: Z-0969-2010 · Initiated September 18, 2009

Recall

Recall Number
Z-0969-2010
Event Number
54152
Firm
Becton Dickinson & Co.
FEI Number
1119779
Product Code
MKZ
Status
Terminated
Root Cause
Employee error
Initiated
September 18, 2009
Posted
March 3, 2010
Terminated
March 24, 2010
Address
7 Loveton Cir, Sparks, MD, 21152-9212

Description

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.

Reason

Product was shipped beyond its expiration date.

Action

The recalling firm notified end users by letter flagged as "Urgent Product Recall" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.

Distribution

The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.

Quantity

242 packs