Z-0125-2021 Class II Terminated
FDA device recall Z-0125-2021 was initiated by Becton Dickinson & Company on September 14, 2020 and is designated Class II. 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 The recall status is terminated (terminated September 27, 2021). Affected quantity: 12,020 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 14, 2020
- Termination Date
- September 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,020 units
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
Distribution Pattern
US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
Code Information
Lot Number: 9325212 UDI: 30382903835387