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.
- Company
- Becton Dickinson & Company
- Recall Initiated
- September 14, 2020
- Terminated
- September 27, 2021
- Recall Number
- Z-0125-2021
- Quantity
- 12,020 units
- Firm Location
- Franklin Lakes, NJ
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
US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
Lot / Code Info
Lot Number: 9325212 UDI: 30382903835387
Root Cause
Nonconforming Material/Component
Action Taken
Siemens issued an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/20 to Distributors/Medical Facilities on 9/14/20 via FedX , email or faxed stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. BD Customer/Technical Support, (844) 823-5433 Monday Friday between 8:30am and 5:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.