The Recall Desk

FDA (Devices) recall action 86994

Becton Dickinson & Company recalled 2 products on 2021-02-03

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
2021-02-03
Critical
0
Units
122,130

Why these products were recalled

BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2021-02-03

    BD Regional Block Needles Recalled for Missing Contraindications in Instructions

    Becton Dickinson is recalling BD Regional Block Needles because the instructions for use lack general contraindications, as advised by the European Notified Body.

    Product
    BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2021-02-03

    BD Stimex Insulated Needle Recall for Missing Contraindications

    Becton Dickinson is recalling BD Stimex Insulated Needles because the instructions for use lack general contraindications.

    Product
    BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
    Category
    Distribution
    18 states