Device recall

Z-1054-2010: Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites…

FDA device recall · Class II · Hospira Inc.

Key facts

Recall number (Z-number) Z-1054-2010
Recall event 54080
Product Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160470701, REF 16047.
Product code FPA
Recalling firm Hospira Inc.
Recall class Class II
Status Terminated
Termination date Jan 29, 2012
510(k) numbers K041550
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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