CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report

Sterile IV Start Kits/trays Convenience kit for IV start procedures recalled

B. Braun Medical is recalling Sterile IV Start Kits/trays Convenience kit for IV start procedures, distributed nationwide in the US. The recall was initiated on 29 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Quantity recalled15,950 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-0691-2017
FDA event ID: 75291
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jul 2016
FDA classified: 1 Dec 2016
Reported: 7 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

29 Jul 2016	Recall initiated by company
1 Dec 2016	Classified by FDA	+125 days
7 Dec 2016	Published in enforcement report	+6 days

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

Reason for recall

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

Where it was distributed

Nationwide Distribution to GA, IL, and FL

Nationwide Florida Georgia Illinois

Questions about this recall

Why was it recalled?

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

Which lots are affected?

Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Where was it sold?

Nationwide Distribution to GA, IL, and FL

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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