Device recall

Z-0346-04: Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile…

FDA device recall · Class III · Cardinal Health

Key facts

Recall number (Z-number) Z-0346-04
Recall event 28002
Product Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
Product code HMX
Recalling firm Cardinal Health
Recall class Class III
Status Terminated
Termination date Apr 8, 2004
FEI number 3004293943

At a glance

  • None 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

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