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The Food and Drug Administration has announced the recall of Closercare insulin syringes and the extension of an earlier recall of Ultilet insulin syringes due to bacterial contamination with Paenibacillus.
The recall includes Closercare insulin syringe 29g 1cc with lot number 5JCZ1 as displayed on the inner case.
The recall also includes Ultilet insulin syringe 30g 1/2 cc with product lot number 5KEO1.
Patients with products from these lots should stop use and return the syringes to the manufacturer.
This bacterial contamination presents a risk of local infection, as well as a risk of the introduction of contaminating organisms into a previously sterile vial.
Moreover, the introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.
For more information, contact Boca Medical Products Inc. by calling 800–354–8460.
The Food and Drug Administration has announced the recall of Closercare insulin syringes and the extension of an earlier recall of Ultilet insulin syringes due to bacterial contamination with Paenibacillus.
The recall includes Closercare insulin syringe 29g 1cc with lot number 5JCZ1 as displayed on the inner case.
The recall also includes Ultilet insulin syringe 30g 1/2 cc with product lot number 5KEO1.
Patients with products from these lots should stop use and return the syringes to the manufacturer.
This bacterial contamination presents a risk of local infection, as well as a risk of the introduction of contaminating organisms into a previously sterile vial.
Moreover, the introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.
For more information, contact Boca Medical Products Inc. by calling 800–354–8460.
The Food and Drug Administration has announced the recall of Closercare insulin syringes and the extension of an earlier recall of Ultilet insulin syringes due to bacterial contamination with Paenibacillus.
The recall includes Closercare insulin syringe 29g 1cc with lot number 5JCZ1 as displayed on the inner case.
The recall also includes Ultilet insulin syringe 30g 1/2 cc with product lot number 5KEO1.
Patients with products from these lots should stop use and return the syringes to the manufacturer.
This bacterial contamination presents a risk of local infection, as well as a risk of the introduction of contaminating organisms into a previously sterile vial.
Moreover, the introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.
For more information, contact Boca Medical Products Inc. by calling 800–354–8460.