Recall Z-1946-2020— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-03-17, terminated 2020-10-21. It names one FDA 510(k) clearance: K170158. Product: PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D. Reason: Iincorrectly packaged without the required lidocaine as labeled.
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-17
- Terminated
- 2020-10-21
- 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
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Reason for recall
Iincorrectly packaged without the required lidocaine as labeled
Data sourced from openFDA. This site is unofficial and independent of the FDA.