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Recall Observatory FDA recall evidence

Device product

Perifix¿ / Epidural anesthesia kit (10 count carton)

Z-2002-2023

June 05, 2023

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 92523
Status
Ongoing
Classification
Class II
Quantity
16,070 units
Official record key
device-enforcement:Z-2002-2023

Official wording

Reason: Kits were assembled with the incorrect Filter Straw.

Code information: Model No. 332217, 332097, 332220, 332078; GTIN: 04046964178283, 04046964177361, 04046964177361, 04046964178320, 04046964177200; Lot No. 0061850767, 0061855339, 00618553400061858554, 0061837264.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits were assembled with the incorrect Filter Straw.