Johnson & Johnson issued a voluntary recall for 70,000 syringes due to cracks.
New Brunswick, N.J.-based medical products giant said the products’ labeling covers the crack site and the flaw could affect the sterility of the syringe’s contents.
The crack was discovered during a routine review, the company said in a letter (PDF) posted on its website.
The syringes, which are manufactured at a facility in Belgium, are pre-filled with 234-milligram-strength injections of Invega Sustenna, an anti-psychotic drug made by Titusville, N.J.-based JNJ-subsidiary Janssen.
The Food & Drug Administration tapped Medtronic’s implantable infusion pump labeling issues as a Class I recall, meaning the agency believes there’s a possibility the device could cause serious injury or death.
Medtronic is updating the labeling of its SynchroMed II and EL pumps and associated refill kits in response to reports of "pocket fills," or an inadvertent injection during a refill procedure, the company said. The pumps are indicated for the delivery of pharmaceuticals such as pain-management drugs.
The Fridley, Minn.-based company is not retrieving the product from the field or recommending the removal of the product. It issued a letter (PDF) to healthcare providers on Jan. 14 to warn of the potential for unwanted injections and alert them of forthcoming labeling changes.
The company reported that there have been 351 incidences from so-called pocket fills, 270 of which have required medical attention and 8 of which have resulted in patient deaths. The inadvertent injections occurred in about one in every 10,000 procedures, according to the company.