FDA product code PEZ: Central Venous Catheter Dressing Change Kit

PEZ is the FDA product code for central venous catheter dressing change kit. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. Devices under PEZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for PEZ devices.

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Classification

Recalls for PEZ devices

4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-09-08.

Frequently asked questions

What is FDA product code PEZ?

PEZ is the FDA product code for central venous catheter dressing change kit. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.

What device class is PEZ?

Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k) exempt.

Have PEZ devices been recalled?

Yes: 4 product recalls across 3 recall events; the most recent began 2021-09-08.

Next steps

• Run an FDA pathway report with predicate devices for product code PEZ
• Run a recall and safety report across every PEZ manufacturer
• Watch product code PEZ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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