Recall archive
117 recalls · page 4 of 5
Reported Mar 12, 2014
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility; potential leakage from administrative port.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 29, 2014
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded…
FDA (openFDA drug enforcement)
Reported Jan 22, 2014
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and…
FDA (openFDA drug enforcement)
Reported Jan 8, 2014
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
FDA (openFDA drug enforcement)
Reported Dec 25, 2013
0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product · Product details — Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 18, 2013
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details · Reason for recall — Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner…
FDA (openFDA device enforcement)
Reported Nov 27, 2013
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand — The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Reason for recall — Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
FDA (openFDA drug enforcement)
Reported Oct 16, 2013
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility; potential for vial breakage
FDA (openFDA drug enforcement)
Reported Oct 9, 2013
5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter; report of visible particulates in the glass ampule
FDA (openFDA drug enforcement)
Reported Sep 18, 2013
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample…
FDA (openFDA drug enforcement)
Reported Sep 4, 2013
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter; product may contain fibrous material
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 21, 2013
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
FDA (openFDA drug enforcement)
Reported Aug 14, 2013
List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details · Reason for recall — It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2013
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — The devices secondary audio signal fails to activate.
FDA (openFDA device enforcement)
Reported Jul 31, 2013
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between…
FDA (openFDA drug enforcement)
Reported Jul 24, 2013
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details · Reason for recall — Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve.…
FDA (openFDA device enforcement)
Reported Jul 17, 2013
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: visible particles were identified floating in the primary container.
FDA (openFDA drug enforcement)
Reported Jul 3, 2013
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details · Reason for recall — Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
8 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 26, 2013
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
FDA (openFDA drug enforcement)
Reported Jun 12, 2013
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported May 15, 2013
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
3 more products in this recall
FDA (openFDA drug enforcement)
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