B. Braun Recalls Sprotte Spinal Needles Missing Introducer Needles
B. Braun Medical is recalling 24-gauge Sprotte Spinal Needles and Trays because the accompanying introducer needles are missing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a component defect.
Plain-English summary
B. Braun Medical, Inc. (BBMI) is recalling 7,400 units of 24-gauge Sprotte Spinal Needles and Sprotte Spinal Trays. The recall involves specific lots of the Sprotte Spinal Tray and Sprotte Pencil Point Spinal Needle with Introducer, which are used for the spinal injection of anesthetics to provide regional anesthesia.
The recall was initiated after BBMI received reports that the 24-gauge Sprotte Needles were missing the accompanying introducer needles. The affected products were distributed nationwide in the United States and to Canada.
Healthcare providers and consumers should stop using the affected lots immediately and contact B. Braun Medical, Inc. for instructions on how to return the products or obtain replacements.
The recalled product
- Product
- Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 7,400
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 (9)
- catalog no. 333740
- lot no. 61358613
- exp. 4/30/2015: Sprotte Spinal Tray
- 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741
- lot no 61352071
- lot no.61350129
- exp. 5/31/2015: Sprotte Spinal Tray
- 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5% catalog no. 560581
- lot no.61354298
Distribution
Distributed nationwide across the United States.
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