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.
What this means for you
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.
- Hazard
- component-defect
- incorrect-filter
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.
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