Central lines, IV solutions, test strips recalled

Details on the latest recalls, warnings, and approvals.


Recalls

A recall of 360 lots of single-lumen central venous catheters and pressure monitoring sets and trays by Cook Medical because of catheter tip fracture and/or separation. Globally, 17,827 devices are subject to this recall. No related illnesses or injuries have been reported.

Photo by Thinkstock
Photo by Thinkstock

A recall of 4 lots of IV solutions by Baxter due to the potential for leaking containers and particulate matter. Leaking containers were confirmed in 11 units of 1 lot of 0.9% sodium chloride injection, and a single unit in a separate lot contained a fragment of cardboard particulate matter. A unit from 1 lot of metronidazole injection contained cloth fiber particulate matter, and a unit from 1 lot of Clinimix E 5/15 (5% amino acid with electrolytes in 15% dextrose with calcium) contained a small fragment of dried skin particulate matter.

A recall of 1 lot of 0.9% sodium chloride irrigation by Baxter, 500-mL plastic pour bottle solution, because of the presence of particulate matter, identified as an insect. There have been no reports of adverse events related to this recall.

A class I recall of the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip because they may report falsely low blood glucose levels. This potential inaccuracy poses a risk that clinicians would not diagnose hyperglycemia in a timely manner and might fail to treat elevated blood glucose levels. There have been no related reports of illness or injury.

A recall of certain lots of Syrspend SF and Syrspend SF Grape suspending agents because of microbial contamination with yeast. If an immunocompromised patient ingests the contaminated product, the patient may develop an infection and require systemic antimicrobial therapy. No related adverse events have been reported.

A recall of morphine sulfate, 0.5 mg/mL preservative-free in 0.9% sodium chloride, 1-mL syringe by Pharmakon Pharmaceuticals because the product is super-potent. Injecting a patient with super-potent morphine could lead to respiratory depression, coma, and death. The recalled product was distributed to 2 medical facilities, 1 in Indiana and 1 in Illinois. Serious adverse events were reported in 3 infants.

A class I recall of Optisure dual-coil defibrillation leads because a manufacturing error may have caused damage to the insulation layer of one of the shock coils. Under certain circumstances, this damage could result in the inability of the defibrillator to deliver electrical therapy to the patient. The recall relates to 447 Optisure leads, 278 of which were distributed in the U.S. The manufacturer has received no reports of lead malfunction or patient injury related to this issue.

A class I recall of 117 Oxylog 2000 plus, 3000, and 3000 plus emergency transport ventilators because an electrical issue may cause a halt in ventilation therapy if the control knobs are not regularly used. The manufacturer has been in contact with customers with instructions on how to release the electrical contact resistance in the control knobs.

Approvals

Elbasvir and grazoprevir (Zepatier) for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 in adult patients. The oral drug may be used with or without ribavirin. In clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 with and without cirrhosis, 94% to 97% of genotype 1-infected patients and 97% to 100% of genotype 4-infected patients achieved sustained virologic response after 12 or 16 weeks on the drug, taken once daily with or without ribavirin. The most common side effects without ribavirin were fatigue, headache, and nausea. With ribavirin, the most common side effects were anemia and headache. The product carries a warning that elevations of liver enzymes to more than 5 times the upper limit of normal occurred in about 1% of clinical trial participants, generally at or after 8 weeks of treatment. Patients with moderate or severe liver impairment should not take the drug.

Eribulin mesylate (Halaven), a type of chemotherapy, for the treatment of unresectable or metastatic liposarcoma in patients who received prior chemotherapy containing an anthracycline drug. The orphan drug is the first to demonstrate an improvement in survival time in patients with liposarcoma. A clinical trial of 143 patients found that the median overall survival in patients taking the drug was 15.6 months, compared to 8.4 months for those taking dacarbazine, another chemotherapy drug. The most common side effects were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The drug may also cause neutropenia or decreased levels of potassium or calcium.

An expanded indication for the Integra Omnigraft Dermal Regeneration Matrix to treat certain diabetic foot ulcers that last longer than 6 weeks. The device, which is made of silicone, cow collagen, and shark cartilage, covers the ulcer and allows skin and tissue to regenerate and heal the wound. Its new indication is based on a clinical study that showed it improved ulcer healing compared to standard diabetic foot ulcer care (51% vs. 32% of patients, respectively, had healed ulcers after 16 weeks). Adverse events included infections, increased pain, swelling, nausea, and new or worsening ulcers. The device should not be used on infected wounds or in patients with allergies to bovine collagen or chondroitin.