Device recall

Z-0208-2018: Solus Flexible wire-reinforced laryngeal mask airways under the following sizes…

FDA device recall · Class II · Intersurgical Inc

Key facts

Recall number (Z-number) Z-0208-2018
Recall event 76945
Product Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent…
Product code BYG
Recalling firm Intersurgical Inc
Recall class Class II
Status Terminated
Termination date Jun 17, 2019
FEI number 1000120301

At a glance

  • None 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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