Device recall

Z-1351-2010: Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity…

FDA device recall · Class II · Hospira Inc.

Key facts

Recall number (Z-number) Z-1351-2010
Recall event 54079
Product Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with secure lock for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica…
Product code FPA
Recalling firm Hospira Inc.
Recall class Class II
Status Terminated
Termination date Jan 29, 2012
510(k) numbers K832755
FEI number 3013319212

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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