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Terminated

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

FDA Recall Z-1710-2019 · Posted None

Recall StatusTerminated
Product CodeFOZ
Date Initiated2019-03-01
Date Terminated2020-05-21
Product Quantity6,720 units

Reason for Recall

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

Firm Action

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

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

US distribution to one distributor in VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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