Busse Lumbar Puncture Tray Recalled for Foreign Matter
Busse Hospital Disposables is recalling Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a quality control issue (foreign matter) without reported adverse health consequences, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 1,037 units of the Lumbar Puncture Tray, Catalog # 1862. The product is used for surgical procedures and was distributed nationwide in the United States.
The recall is being issued because the product may contain loose polypropylene foreign matter above release specifications. The source text identifies the specific component involved as the BD SafetyGlide Needle 22GA 1-1/2 inch.
Affected lots include 1710206, 1710040, 1610536, 1610423, 1610351, 1610219, and 1610090. Expiration dates range from 12/30/2021 to 05/30/2022, with some lots having no expiration date. Healthcare facilities should stop using these trays and contact the manufacturer for instructions.
The recalled product
- Product
- Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
- Hazard
- Affected units
- 1,037
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 (7)
- Lot Numbers/Expiration Dates: 1) 1710206/Expiration Date: 05/30/2022
- 2) 1710040/Expiration Date: 01/30/2022
- 3) 1610536/Expiration Date: 12/30/2021
- 4) 1610423/No Expiration Date
- 5) 1610351/No Expiration Date
- 6) 1610219/No Expiration Date
- 7) 1610090/No Expiration Date
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables 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.
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