Device recall

Z-1463-2012: GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7…

FDA device recall · Class II · Hospira Inc.

Key facts

Recall number (Z-number) Z-1463-2012
Recall event 61472
Product GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician…
Product code FRN
Recalling firm Hospira Inc.
Recall class Class II
Status Terminated
Termination date Sep 14, 2016
510(k) numbers K023062
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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