FDA Enforcement Class III Terminated

BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

Recall: Z-1056-2013 · Reported April 10, 2013

Enforcement

Recall Number
Z-1056-2013
Event ID
64494
Classification
Class III
Status
Terminated
Product Type
Devices
Firm
Becton Dickinson & Company
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
April 10, 2013
Initiation Date
February 14, 2013
Classification Date
April 4, 2013
Termination Date
August 6, 2013
Address
1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

Description

BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

Reason

The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible

Code Info

Catalog #3694991 appears as Catalog #364953 (Lot #1335484)

Distribution

Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.

Quantity

236,400 units