Important Safety Alerts

Medical device manufacturer, Baxter Healthcare, has issued a field safety notice (FSN) concerning its Coseal Surgical Sealant 2ml and 4ml sizes. The affected lot numbers and expiration dates are as follows:

• For Coseal 2ml, Product code 934073:
  • Lot number HA130436; Expiration date: 31 July 2014
  • Lot number HA130719; Expiration date: 31 December 2014
  • Lot number HA131230; Expiration date: 31 May 2015
  • Lot number HA140448; Expiration date: 30 September 2015
• For Coseal 4ml, Product code 934074:
  • Lot number HA130538; Expiration date: 31 October 2014
  • Lot number HA130721; Expiration date: 31 December 2014
  • Lot number HA131229; Expiration date: 31 May 2015
  • Lot number HA140230; Expiration date: 31 July 2015
  • Lot number HA140429; Expiration date: 30 September 2015

According to the manufacturer, Coseal is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage, as well as enforcement of suture and staple lines in lung resection procedures; patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post-surgical adhesion formation; and patients undergoing laparotomy or laproscopic abdomino-pelvic as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post-surgical adhesion formation.

The recall is being conducted as a precautionary measure due to out of specification results observed at the 18-month time point (out of 18-month licensed shelf life to expiration) during a Coseal stability study.

The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. All other stability requirements were met.

According to the FSN, Coseal's failure to gel does not represent risk for the patient's life, and has no potential to induce any harm. Coseal is an adjunct, and not a replacement for standard surgical techniques.

The manufacturer is recalling the affected products.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 July 2014