Device recall

Z-1119-2022: Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200…

FDA device recall · Class II · Steris Corporation

Key facts

Recall number (Z-number) Z-1119-2022
Recall event 90050
Product Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Product code EFQ
Recalling firm Steris Corporation
Recall class Class II
Status Terminated
Termination date Jan 29, 2024
510(k) numbers K984187
FEI number 1527821

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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