Device recall

Z-0810-03: Portex 1st Response Adult Manual Resuscitators Ref: 8503P

FDA device recall · Class I · Sims Portex Inc.

Key facts

Recall number (Z-number) Z-0810-03
Recall event 25083
Product Portex 1st Response Adult Manual Resuscitators Ref: 8503P
Product code BTM
Recalling firm Sims Portex Inc.
Recall class Class I
Status Terminated
Termination date May 11, 2004
510(k) numbers K014115
FEI number 1217052

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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