Millar Instruments Inc. pulled more than 1,000 of its angiographic catheters over fears that one of its components could contain debris, while H&P Industries Inc. recalled all of its Providine Prep antiseptic pads after the company discovered a serious infection-causing bacteria on the products.
The FDA has not yet classified either recall, but both companies said that use of the affected products could result in death.
Houston-based Millar found that the lumen component of models SPC-454D and SPC-454F of its angiographic catheter contain particulates that could enter the blood stream and cause heart attack, stroke, limb ischemia and death, according to the company. The firm said it emailed and called all of its affected customers and no adverse affects have been reported.
The recall affects all SPC-454D and SPC-454F catheters that expire after March 2011. A total of 965 catheters were distributed to the company’s international distributors and 115 catheters were distributed to Millar customers in California, Washington, D.C., Massachusetts, Michigan, Minnesota, New York and Pennsylvania.
Hartland, Wis.-based H&P Industries issued its recall due to results from an internal probe in addition to an ongoing FDA investigation.
The company reported that the bacteria Elizabethkingia meningoseptica, infections from which have limited treatment options, was found on the pads.
H & P took all lots of the antiseptic pads off the shelves following an earlier recall of alcohol prep pads, swabs and swabsticks, which prompted the investigation by the watchdog agency.
The non-sterile pads use the same materials as the recalled alcohol prep pads, according to the company.
The products are individually packaged and sold under a number of labels, including Cardinal Health, Medical Specialities, VHA, Triad, Triad Plus, North Safety and Total Resources. No contaminated pads were sold outside the U.S., according to the company. No adverse events related to the products have been reported, the company said.