Recall Z-0125-2021— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-09-14, terminated 2021-09-27. It names one FDA 510(k) clearance: K183399. Product: BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.. Reason: Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted.
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-14
- Terminated
- 2021-09-27
- 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 Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Reason for recall
Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
Data sourced from openFDA. This site is unofficial and independent of the FDA.