Device recall

Z-0775-2012: CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made…

FDA device recall · Class II · Smiths Medical ASD, Inc.

Key facts

Recall number (Z-number) Z-0775-2012
Recall event 60883
Product CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to allow fluid delivery from an IV bag. EXPANDED: Catalog No./ REF 21-7381-01
Product code FPA
Recalling firm Smiths Medical ASD, Inc.
Recall class Class II
Status Terminated
Termination date Nov 6, 2012
510(k) numbers K991301
FEI number 2183502

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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

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