Recall archive
117 recalls · page 5 of 5
Reported May 8, 2013
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand — Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2013
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 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: A single visible particulate was identified during a retain sample inspection.
FDA (openFDA drug enforcement)
Reported Apr 24, 2013
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2013
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36…
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 is being recall due to the product lot being incorrectly released without meeting product specifications.…
FDA (openFDA drug enforcement)
Reported Apr 3, 2013
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10…
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 vials was observed and confirmed in a sample bottle during retain inspection.
FDA (openFDA drug enforcement)
Reported Mar 27, 2013
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC…
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: There is the potential for the solution to leak from the administrative port to the fill tube seal.
FDA (openFDA drug enforcement)
Reported Mar 13, 2013
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
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: There is the potential for solution to leak from the administrative port to the fill tube seal.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 6, 2013
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045,…
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: There is a potential for the solution to leak from the administration port of the primary container.
FDA (openFDA drug enforcement)
Reported Mar 6, 2013
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC…
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; possible loose crimp applied to fliptop vial
FDA (openFDA drug enforcement)
Reported Feb 20, 2013
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC…
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 and particulate embedded in vials were observed during retain inspection.
FDA (openFDA drug enforcement)
Reported Feb 13, 2013
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 9, 2013
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 19, 2012
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2012
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product · Product details — The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2012
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain…
FDA (openFDA drug enforcement)
Reported Sep 26, 2012
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — Embedded iron oxide glass defect which may have the potential to break off into the solution.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 5, 2012
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: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
FDA (openFDA drug enforcement)
Reported Aug 22, 2012
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product details — Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
FDA (openFDA drug enforcement)
Reported Aug 15, 2012
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled…
FDA (openFDA drug enforcement)
Reported Aug 1, 2012
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — The float valve in the burette sticks to the burette wall and does not open or close properly.
FDA (openFDA device enforcement)
Reported Jul 25, 2012
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
FDA (openFDA drug enforcement)
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