Recall archive
117 recalls · page 3 of 5
Reported Feb 25, 2015
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 11, 2015
Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 4, 2015
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
FDA (openFDA drug enforcement)
Reported Jan 14, 2015
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, 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: The product has the potential for solution to leak at the administrative port.
FDA (openFDA drug enforcement)
Reported Dec 31, 2014
Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product · Product details — Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 24, 2014
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of…
FDA (openFDA drug enforcement)
Reported Dec 17, 2014
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility; improperly crimped fliptop vials
FDA (openFDA drug enforcement)
Reported Dec 3, 2014
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2014
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product details — Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
FDA (openFDA drug enforcement)
Reported Nov 5, 2014
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand — The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2014
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
FDA (openFDA drug enforcement)
Reported Oct 22, 2014
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass…
FDA (openFDA drug enforcement)
Reported Oct 8, 2014
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira,…
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 discolored solution with visible metal particles embedded in the glass vial and…
FDA (openFDA drug enforcement)
Reported Oct 1, 2014
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
FDA (openFDA drug enforcement)
Reported Sep 24, 2014
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the…
FDA (openFDA drug enforcement)
Reported Aug 27, 2014
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc.,…
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: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 23, 2014
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
FDA (openFDA drug enforcement)
Reported Jul 16, 2014
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details · Reason for recall — Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2014
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 28, 2014
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following…
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2014
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Reason for recall — Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Reason for recall — Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2014
Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc.,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product · Product details — Labeling; Missing label; ampoules are missing the immediate container label
FDA (openFDA drug enforcement)
Reported Mar 26, 2014
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be…
FDA (openFDA drug enforcement)
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