Device recall

Z-2220-2019: Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including…

FDA device recall · Class II · ROi Consolidated Service Center (CSC)

Key facts

Recall number (Z-number) Z-2220-2019
Recall event 82499
Product Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Product code KDD
Recalling firm ROi Consolidated Service Center (CSC)
Recall class Class II
Status Open, Classified
FEI number 3004513970

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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