Device recall

Z-0817-2012: Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile…

FDA device recall · Class II · Hospira Inc.

Key facts

Recall number (Z-number) Z-0817-2012
Recall event 60869
Product Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 14203-28. Intended use: for the administration of blood products.
Product code FPA
Recalling firm Hospira Inc.
Recall class Class II
Status Terminated
Termination date Aug 29, 2016
510(k) numbers K101677
FEI number 3013319212

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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