CLASS II Device recall · Reported 1 Jun 2016 · FDA Enforcement Report

WHIN Infusion Set - 90 Huber Needle and Wing recalled

B. Braun Medical is recalling WHIN Infusion Set - 90 Huber Needle and Wing (/. Intravenous delivery through, distributed in 18 states. The recall was initiated on 26 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.

Quantity recalled5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1703-2016
FDA event ID: 74171
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 26 Apr 2016
FDA classified: 20 May 2016
Reported: 1 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 Apr 2016	Recall initiated by company
20 May 2016	Classified by FDA	+24 days
1 Jun 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

Product as listed by the FDA

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

Where it was distributed

Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.

Alabama Arkansas California Florida Georgia Illinois Indiana Kentucky Massachusetts Mississippi New Jersey Nevada Ohio Pennsylvania South Carolina Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

Which lots are affected?

Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.

Where was it sold?

Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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