Device recall

Z-1491-2012: LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48…

FDA device recall · Class II · Hospira Inc.

Key facts

Recall number (Z-number) Z-1491-2012
Recall event 61680
Product LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.
Product code FRN
Recalling firm Hospira Inc.
Recall class Class II
Status Terminated
Termination date Dec 15, 2016
510(k) numbers K865060
FEI number 3013319212

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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