J&J Surgical Wound Drainer Recall: Sterility Problems

Once again, a Johnson & Johnson subsidiary has issued a massive recall over potential safety concerns surrounding one of their products. This time, Ethicon, Inc. has recalled about 360,000 surgical wound drainers sold under the Black and J-VAC labels, due to potential concerns that the packaging may not keep them sterile.

The surgical wound drainer recall was announced on March 25, in a letter to customers (pdf). According to Ethicon, which is owned by Johnson & Johnson, customers have been complaining that the packaging appears to compromise the sterility of the medical devices.

The Ethicon surgical wound drainer recall notice indicates that while there have been no illnesses reported in connection to unsterile wound drainers, the company is withdrawing the products anyway out of an abundance of caution.

The recall affects the Blake Silicon Drain, Blake Silicone drain kit, Blake Cardio Connector, J-VAC Reservoir and the J-VAC Drain Adapter. Numerous product codes, lot numbers and expiration dates are affected.

The letter contains detailed instructions for how health care providers can safely package and return the products. 

This is the latest in a string of recalls issued by Johnson & Johnson and their subsidiaries over the past year due to manufacturing problems.

Ethicon recalled more than half a million medical sutures due to sterility problems earlier this month. In addition, Johnson & Johnson subsidiaries have also recalled 700,000 vials of Dermabond Topical Skin Adhesive and Simponi autoinjectors, as well as 70,000 syringes of Invega, in just the last few weeks.

National attention has been focused on Johnson & Johnson and their quality controls following an April recall of Tylenol, Benadryl and Motrin, which affected affected 136 million bottles of children’s medications. That recall resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant and the suspension of the production of all children medications manufactured by their McNeil subsidiary.

The ongoing problems with Johnson & Johnson  have resulted in Congressional hearings and have increased the likelihood that the FDA will receive increased powers to regulate drug makers. There have also been a number of Johnson & Johnson class action and individual lawsuits filed as a result of the ongoing problems.