Recall archive
117 recalls · page 2 of 5
Reported Jul 20, 2016
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through…
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 PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25…
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: Confirmed customer complaint for the presence of particulate matter.
FDA (openFDA drug enforcement)
Reported Jul 6, 2016
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2016
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Cardboard
FDA (openFDA drug enforcement)
Reported Jun 15, 2016
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest,…
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: particulate matter identified as an insect in one vial.
FDA (openFDA drug enforcement)
Reported May 25, 2016
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product details — Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
FDA (openFDA drug enforcement)
Reported May 11, 2016
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product details — Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label…
FDA (openFDA drug enforcement)
Reported Apr 27, 2016
Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 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 — Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 2, 2016
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2016
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product details — Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
FDA (openFDA drug enforcement)
Reported Nov 4, 2015
Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. d.b.a. Integra Pain Management
Matched: Product details · Reason for recall — Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is…
FDA (openFDA device enforcement)
Reported Oct 28, 2015
Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hospira Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability…
FDA (openFDA drug enforcement)
Reported Sep 23, 2015
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Defective Container: There were customer complaints of cracked and leaking glass vials.
FDA (openFDA drug enforcement)
Reported Jul 22, 2015
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728,…
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 channel leaks near the threaded vial port.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 15, 2015
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. 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: Presence of free-floating and embedded iron oxide particles.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 3, 2015
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product · Product details — Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently…
FDA (openFDA drug enforcement)
Reported May 20, 2015
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, 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 — Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as…
FDA (openFDA drug enforcement)
Reported May 13, 2015
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, 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: Confirmed finding of human hair floating in IV solution.
FDA (openFDA drug enforcement)
Reported May 6, 2015
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, 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 — Crystallization
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 29, 2015
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand — The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 2015
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand · Product · Product details — Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 25, 2015
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hospira Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
FDA (openFDA drug enforcement)
Reported Mar 4, 2015
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hospira Inc.
Matched: Brand — One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
4 more products in this recall
FDA (openFDA device enforcement)
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