Recall Z-0193-2020— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-07-31, terminated 2020-07-27. It names one FDA 510(k) clearance: K011984. Product: BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.. Reason: Separation of front and rear barrels upon activation of the safety feature that retracts the needle.
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-31
- Terminated
- 2020-07-27
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.
Reason for recall
Separation of front and rear barrels upon activation of the safety feature that retracts the needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.