—#171364

Product

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K161777
Affected lot / code info: Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362

Why it was recalled

Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

BD MDS (Medication Delivery Solutions) contacted via email and provided a hard copy letter via FedEx on March 1, 2019. The tetter describes the problem , action to take: Immediately review your inventory for the specific Catalog and lot number listed above.Destroy all product subject to the recall following your institutions process for destruction. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. . 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 and process your product replacement BD is requesting the distributor to identify their customers and either notify their customers regarding the recall or provide BD a customer list. BD will mail additional communications to the customers that are identified on the lists provided by the distributor. Questions: Customer/Technical Support 888-237-2762 OPT 3, OPT 2 Monday Friday between 8:00am and 5:00pm (EST

Recalling firm

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

Distribution

Distribution pattern: US distribution to one distributor in VA.

Timeline

Recall initiated: 2019-03-01
Terminated: 2020-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.