Device recall

Z-2228-2011: Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal…

FDA device recall · Class II · Deroyal Industries, Inc. Lafollette

Key facts

Recall number (Z-number) Z-2228-2011
Recall event 58675
Product Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA.
Product code LRP
Recalling firm Deroyal Industries, Inc. Lafollette
Recall class Class II
Status Terminated
Termination date Aug 6, 2014
FEI number 3005011024

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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