Device recall

Z-0524-2012: Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk…

FDA device recall · Class II · Heritage Labs International LLC

Key facts

Recall number (Z-number) Z-0524-2012
Recall event 57863
Product Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and a form to accompany the specimen . Blood specimen collection
Product code JKA
Recalling firm Heritage Labs International LLC
Recall class Class II
Status Terminated
Termination date Dec 26, 2012
510(k) numbers K883787
FEI number 1000118383

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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