FDA-Device2023-07-05Class II

Design Options¿ / Epidural anesthesia kit (10 count carton)

Hazard

Kits were assembled with the incorrect Filter Straw.

Sold states
US Nationwide distribution.
Affected count
3,560 units
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
Design Options¿ / Epidural anesthesia kit (10 count carton)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2003-2023

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