The Recall Desk

FDA (Devices) recall action 75908

Bard Access Systems recalled 2 products on 2017-01-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-01-18
Critical
0
Units
44,500

Why these products were recalled

Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2017-01-18

    Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers

    Bard Access Systems is recalling StatLock PICC Plus Crescent Foam devices because some pouches lack unique product identifiers like lot numbers.

    Product
    StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may co
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-01-18

    Bard Access Systems Recalls StatLock Catheter Stabilization Devices

    Bard Access Systems is voluntarily recalling StatLock CV Plus catheter stabilization devices because some pouches lack unique product identifiers.

    Product
    StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain
    Category
    Distribution
    0 states