Busse Lumbar Puncture Tray Recalled for Foreign Matter
Busse Hospital Disposables is recalling Safety-Deluxe 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 82 cases of Safety-Deluxe Lumbar Puncture Trays, Catalog # 975. The product is used for surgical procedures and was distributed nationwide in the United States.
The recall was initiated because the BD SafetyGlide Needle 22GA 1-1/2 inch included in the trays may contain loose polypropylene foreign matter that exceeds release specifications. The affected lots have expiration dates ranging from December 2018 to May 2019.
Healthcare facilities and consumers should stop using the affected trays and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
- Hazard
- Affected units
- 82
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 (6)
- Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018
- 2) 1610204/Expiration Date: 02/01/2019
- 3) 1610075/Expiration Date: 06/01/2018
- 4) 1610431/Expiration Date: 05/30/2019
- 5) 1610246/Expiration Date: 02/01/2019
- 6) 1610204/Expiration Date: 02/01/2019
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.
See all 7 products in this recall →Related recalls
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