Device recall

Z-2538-2021: Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing…

FDA device recall · Class II · C.R. Bard Inc

Key facts

Recall number (Z-number) Z-2538-2021
Recall event 88499
Product Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
Product code MJC
Recalling firm C.R. Bard Inc
Recall class Class II
Status Open, Classified
510(k) numbers K070582
FEI number 1018233

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)