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 / number Product 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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