Unsterile Medical Device Recall: Zoll & Kranz, LLC is investigating the Seprafilm Class II Recall

Genzyme Corporation has conducted multiple recalls of thousands of its adhesion barrier product known as Seprafilm.  Zoll & Kranz (ZK) is currently investigating potential cases.

ZK is currently investigating potential cases involving adverse side effects involving Seprafilm. This adhesion barrier product was approved by the FDA for abdominal or pelvic laparotomy in order to reduce the occurrence of postoperative adhesions located between the abdominal wall and the underlying viscera (organs within the abdominal cavity).

The FDA Class II recalls suggest that the use of the product may cause temporary or medically reversible adverse health consequences. Letters have been sent to hospitals advising them of the recall.

Contaminated Seprafilm has been the alleged cause of multiple conditions, including bowels cemented to the abdominal wall and lymphocele. Some of these are reflected in Adverse Event Reports (AERs) in the FDA’s MAUDE database.

Furthermore, Genzyme Corporation was involved in a whistle-blower lawsuit that it recently settled for $22.3 million. Sales representatives allegedly taught doctors other ways to use Seprafilm that were not an approved use.

ZK Law holds pharmaceutical and medical device manufactures accountable and improves injured patients’ lives.