Device recall

Z-0388-04: Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured…

FDA device recall · Class II · Greiner VACUETTE North America

Key facts

Recall number (Z-number) Z-0388-04
Recall event 28126
Product Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
Product code FPA
Recalling firm Greiner VACUETTE North America
Recall class Class II
Status Terminated
Termination date Jun 7, 2004
510(k) numbers K992145
FEI number 3001451379

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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