Recall archive
111 recalls · page 5 of 5
Reported Nov 2, 2016
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AccessClosure, Inc., A Cardinal Health Company
Matched: Brand — AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the…
FDA (openFDA device enforcement)
Reported Oct 19, 2016
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Potential risk associated with corrosion demonstrated on the distraction screw surface.
FDA (openFDA device enforcement)
Reported Oct 12, 2016
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has…
FDA (openFDA device enforcement)
Reported Aug 10, 2016
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AccessClosure, Inc., A Cardinal Health Company
Matched: Brand — A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
FDA (openFDA device enforcement)
Reported Apr 13, 2016
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a…
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Perrigo Company PLC
Matched: Product details — Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
FDA (openFDA drug enforcement)
Reported Dec 30, 2015
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Electronics North America Corporation
Matched: Product · Product details — Heel warmers may cause first and second degree burns.
FDA (openFDA device enforcement)
Reported Oct 28, 2015
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples…
FDA (openFDA device enforcement)
Reported Apr 22, 2015
Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cardinal Health
Matched: Brand · Product details — Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium…
FDA (openFDA drug enforcement)
Reported Feb 11, 2015
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
FDA (openFDA device enforcement)
Reported May 29, 2013
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Alere San Diego, Inc.
Matched: Product · Product details · Reason for recall — Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG…
FDA (openFDA device enforcement)
Reported May 15, 2013
Presource PBDS, Gyn Laparoscopy Kit, Circulator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health, Medical Products & Services
Matched: Brand — Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 30, 2013
Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand · Product · Product details — The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.
FDA (openFDA food enforcement)
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