Device recall

Z-0815-2012: Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch…

FDA device recall · Class II · Mallinckrodt Inc

Key facts

Recall number (Z-number) Z-0815-2012
Recall event 60897
Product Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve the projects upward…
Product code DXT
Recalling firm Mallinckrodt Inc
Recall class Class II
Status Terminated
Termination date Feb 19, 2013
510(k) numbers K781334
FEI number 1518293

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

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