Recall archive
61 recalls · page 3 of 3
Reported Mar 28, 2018
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 21, 2018
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2018
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
FDA (openFDA device enforcement)
Reported Jan 10, 2018
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2017
CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product details · Reason for recall — Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 4, 2017
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot…
FDA (openFDA device enforcement)
Reported Sep 6, 2017
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product details — The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and…
FDA (openFDA device enforcement)
Reported Aug 2, 2017
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.
FDA (openFDA device enforcement)
Reported Jul 12, 2017
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall…
FDA (openFDA device enforcement)
Reported Jun 21, 2017
CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly…
FDA (openFDA device enforcement)
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