J&J's Ethicon unit voluntarily recalls wound draining products

Johnson & Johnson's Ethicon unit is voluntarily recalling multiple lots of Blake silicone drains, drain kits and cardio connectors, as well as J-VAC reservoirs and drain adapters, because the sterile barrier of the product packaging may be compromised. The company became aware of the problem after receiving customer complaints. The recall involves about 360,000 units of products.

The company says in a letter it has not received any reports of adverse events related to this issue, and the FDA has been notified of the recall. Customers are advised to return their product to Stericycle using the enclosed pre-paid shipping label.

Ethicon linked the problem to a contract manufacturer, which it declined to name, according to the Wall Street Journal. "We take full accountability for our supply chain," Ethicon spokeswoman Barbara Montresor said.

Ethicon is no stranger to recalls this year. The unit recently recalled 700,000 vials of a liquid wound-sealing product amid reports of discoloration and a new hernia-treatment product due to concerns about non-sterile packaging. As the WSJ notes, J&J doesn't make sales data available for the Ethicon products, but the unit posted total sales of $4.5 billion last year.

- here is the recall letter
- get more from Mass Device
-
read the WSJ report
- check out the WSJ Health Blog's recall watch of J&J products

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.