Device recall

Z-1016-2017: Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free…

FDA device recall · Class II · Hospira Inc.

Key facts

Recall number (Z-number) Z-1016-2017
Recall event 64220
Product Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Product code FPK
Recalling firm Hospira Inc.
Recall class Class II
Status Terminated
Termination date Apr 24, 2017
510(k) numbers K941214
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

Browse all FDA device recalls (products)