Reported Feb 26, 2014 · Terminated

SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids…

B. Braun Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B. Braun Medical, Inc. · 901 Marcon Blvd · Allentown, PA · 18109-9512

Is this the product you have?

  • SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Lot codes and dates

20 of 20 products

Products covered by this recall
Model / numberProduct as published
351559batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018
352016batch # 0061326956, exp. 10/31/2018
352079batch #0061333591, exp. 8/31/2018
352448batch # 0061334116, exp.9/30/2018
473017batch #0061332459, exp. 8/31/2018
473017batch #061335025, exp. 9/30/2018
473309batch #s 0061343285, exp. 10/31/2018
calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018
474563batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018
490028batch # 0061324733, exp. 8/31/2018
490213batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015
SS3140batch # 0061339123, exp. 9/30/2015
7B0110batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date
7B3179batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date
7B3240batch #s 61324238, exp. 8/31/2018
61329535, exp. 9/30/2018
61336490, exp. 7/31/2018
S5401118Nbatch #0061335969, Bulk Non-Sterile, No Expiration Date
S5401150Nand , batch #61326267, NonSterile
No Expiration Date.
Amount recalled
2,357,944

Where it was sold

  • Nationwide

Why it was recalled

Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 3, 2014 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.