The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2003-2023·Announced 2023-07-05

Design Options Epidural Anesthesia Kit Recalled for Incorrect Filter Straw

B. Braun Medical is recalling Design Options Epidural Anesthesia Kits because certain units were assembled with an incorrect filter straw. The recall affects approximately 3,560 kits distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with a manufacturing defect (incorrect filter straw) that creates a potential risk of harm to patients during medical procedures. No injuries or illnesses are reported in the source, placing this in the high-risk category with theoretical harm potential.

Plain-English summary

B. Braun Medical, Inc. is recalling Design Options® Epidural Anesthesia Kits (10 count cartons) distributed nationwide. The recall affects approximately 3,560 units identified by model numbers 552177, 552155, 552179, and 552116, and lot numbers 0061853751, 0061854949, 0061855598, and 0061855133.

The recalled kits were assembled with an incorrect filter straw during manufacturing. This defect affects the integrity and proper functioning of the epidural anesthesia kit.

Healthcare facilities and providers who have received these products should verify whether their kits match the recalled model and lot numbers. Contact B. Braun Medical, Inc. for information on replacement products or further details regarding this recall.

The recalled product

Product
Design Options¿ / Epidural anesthesia kit (10 count carton)
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
3,560

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Model No. 552177
  • 552155
  • 552179
  • 552116
  • GTIN: 04046955596102
  • 04046955214440
  • 04046955596140
  • 04046964950254
  • Lot No. 0061853751
  • 0061854949
  • 0061855598
  • 0061855133.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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