FDA Deems Teleflex Catheter Kit Recall as Class I

The FDA has deemed as class I the company’s recall of certain Teleflex and Arrow International Pressure Injectable Catheter Kits for a mislabeling issue and Nurse Assist has recalled certain lots of irrigation water for a lack of sterility assurance.

The injectable catheter kits allow access to the central cardiovascular system for patients with conditions that require frequent injections or blood draws. With the kit, a health care provider can sample blood, monitor blood pressure, or administer fluids, medications, or chemotherapy.

The lids of the affected kits incorrectly list the devices as non-coated, however the product is coated with chlorohexidine, a substance that can cause allergic reactions including itching, redness, skin changes, hives, dizziness, drop in blood pressure, difficulty breathing, and anaphylaxis which could lead to death if a person is allergic to chlorohexidine.

Read the FDA’s notice on the catheter kits here.

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