Device recall

Z-2346-2012: Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03…

FDA device recall · Class II · Hospira, Inc.

Key facts

Recall number (Z-number) Z-2346-2012
Recall event 62909
Product Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
Product code MEA
Recalling firm Hospira, Inc.
Recall class Class II
Status Terminated
Termination date May 8, 2014
510(k) numbers K043256
FEI number 3013319212

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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

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