FDA clears use of intravenous device from Costa Rica

PHOTO from fda.gov.ph

MANILA, Philippines—The Food and Drug Administration has lifted a quality hold it had earlier imposed on a burette intravenous set imported from Costa Rica, saying the medical device has passed the sterility test.

The device is used in the administration of intravenous solutions to patients.

In an advisory dated June 9, FDA acting director general Dr. Kenneth Go said Soluset 100 Burette IV Set imported by Hospira Philippines Inc., particularly those with batch numbers 170145G and 170785G, can be put back on store shelves after tests conducted by the FDA Laboratory Unit showed “satisfactory results.”

Go also noted that Hospira Philippines conducted a separate investigation on all the remaining stocks of the medical product, including “historical complaints search, review of batch record, evaluation of the inspection results of visual checking and physical evaluation.”

Following the investigation, proper gowning and wearing of hairnet during coiling, packaging and sealing of the products have been strictly implemented to prevent complaints from arising again, said Go.

“In this regard, the quality hold on Soluset TM Burette Intravenous Set… is hereby lifted, effective immediately. Hospira Philippines Inc. can now sell the products,” said Go.

Soluset 100 Burette IV Set is manufactured by Hospira de Costa Rica Ltd. and registered in the Philippines with FDA registration number DVR-2362.

In November last year, the FDA warned consumers and health professionals against the use of the aforementioned batches of the medical device after the agency and Hospira decided to jointly take up a quality hold on the product.

Distributors and drug outlets were also ordered to remove the product from their shelves and hold them until the FDA and the manufacturer shall have conducted the quality check.