Recall Z-1056-2013— Becton Dickinson & Company
Class III · Terminated
Class III FDA medical device recall by Becton Dickinson & Company, initiated 2013-02-14, terminated 2013-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-02-14
- Terminated
- 2013-08-06
- Firm location
- Franklin Lakes, NJ, United States
Product 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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.