—#183707

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.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K183399
Affected lot / code info: Lot Number: 9325212 UDI: 30382903835387

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.

Timeline

Recall initiated: 2020-09-14
Terminated: 2021-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.