Device recall

Z-0152-2011: Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm)…

FDA device recall · Class II · Baxter Healthcare Corp.

Key facts

Recall number (Z-number) Z-0152-2011
Recall event 56718
Product Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8450 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Product code FPA
Recalling firm Baxter Healthcare Corp.
Recall class Class II
Status Terminated
Termination date Sep 7, 2011
510(k) numbers K781036
FEI number 1416980

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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