FDA warns on widened reach of Nurse Assist's saline, sterile water recall

2024-02-26

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来源: FierceBiotech

Though Nurse Assist said in its November recall notice that it had yet to receive any reports of adverse events linked to any of the affected products, the FDA said this month that it “is receiving reports of adverse events associated with use of Nurse Assist products and is further evaluating this information.”

About three months after first alerting patients and healthcare providers to Nurse Assist’s voluntary recall of several of its sodium chloride irrigation and sterile water products, the FDA is now highlighting the broad reach of the recall and its potential risks.

Nurse Assist, a Texas manufacturer of water-based medical products—typically used to flush out wounds and medical tubing, among other applications—began its recall in early November after finding during routine testing that some saline and water products may not actually be sterile.

The products had been distributed in the U.S. and Canada between November 2021 and mid-September of last year, and the company said in its recall notice that it had yet to receive any reports of adverse events associated with any of the affected products, though it recommended that customers immediately stop using them and contact their distributors for replacements.

Nurse Assist listed out nearly 80 products that were included in the recall. Only a dozen were sold with the company’s own branding; the rest were distributed either individually or within kits sold by Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell and Vyaire.

That broad distribution sparked another round of recall notices and customer alerts from the affected brands, plus an updated FDA notice this month compiling all of the interrelated recalls.

The regulator added in the Feb. 13 alert that it “is receiving reports of adverse events associated with use of Nurse Assist products and is further evaluating this information.”

Medline was among the product distributors to put out its own voluntary recall notice shortly after Nurse Assist’s safety event began last fall. Recalled Medline products include bottles, cups, syringes and spray cans loaded with sterile water and saline for irrigation purposes.

Now this week, 49 separate notices for Medline products were added to the FDA’s recall database—all apparently related to the Nurse Assist recall, and all bearing Class I ratings, the agency’s most serious label when it comes to the possibility of patient harm.

Cardinal Health, meanwhile, issued its own recall in December, covering the Cardinal- and Covidien-branded products included in Nurse Assist’s original warning. Avanos Medical also chimed in with another voluntary recall earlier this month, covering certain lots of its MIC Gastric jejunal feeding tube kits, which contain sterile water syringes supplied by Nurse Assist.

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