Fertility tank firm recalls products
The manufacturer of the storage tank that malfunctioned at San Francisco’s Pacific Fertility Center — destroying or endangering the frozen eggs and embryos of several hundred people — is the same company that recently recalled other storage tanks, according to a lawsuit against the fertility center brought by patients affected by the March 4 incident.
The manufacturer cited in the suit, Chart Industries of Georgia, issued a recall notice for tanks on April 23, acknowledging the potential for a vacuum leak or failure that could compromise the products.
The recall does not apply to the tank at issue at Pacific Fertility Center. Rather, it applies to other tanks used in the shipping or transport of biological tissue samples.
A spokeswoman for Chart declined to comment on whether the tank cited in the incident at Pacific Fertility Center was manufactured by
Chart. She also declined to say how many tanks were recalled.
The recall was issued four days after Pacific Fertility Center notified patients, following an internal investigation, that the cause of the malfunction was a failure in its tank’s vacuum seal, according to an amended complaint filed Wednesday in U.S. District Court for the Northern District of California. The complaint is part of a lawsuit filed by several patients accusing Pacific Fertility of negligence and breach of contract.
On March 4, staff at Pacific Fertility Center discovered that a cryostorage tank had low levels of the liquid nitrogen needed to keep eggs and embryos frozen. On March 11, the clinic notified patients who had their eggs or embryos stored in the affected tank. Some were told their tissue had been destroyed; others were told their tissue may still be viable. About 400 people had tissue stored in the tank, according to attorneys for patients who are suing the clinic.
A spokeswoman for Chart declined to comment on the litigation facing Pacific Fertility Clinic.
“Chart is presently investigating the possible cause of the vacuum leak and/or failure which may be due to inadequate adhesion of the composite neck to the aluminum unit,” according to the recall notice that was sent to Chart customers on April 23 regarding the other tank models. “This issue appears to be an isolated occurrence involving the machine and binding agent used during the manufacturing
process.”
The recall is expected to cost Chart about $3.75 million, according to an April 23 filing with the U.S. Securities and Exchange Commission.
Chart is “the world’s leading manufacturer of vacuum insulated products and cryogenic freezer systems for life sciences markets,” according to the company’s website.
In the recall notice Chart sent to its customers, the company listed 13 partial serial numbers of “aluminum dewar” products to be recalled. Chart did not immediately respond to a question about which models the serial numbers correspond to. On its website, Chart lists 13 aluminum dewar tank models used for storage and transport of biological tissue.
Pacific Fertility Center did not immediately return a request for comment Friday.