The Recall Desk
ModerateFDA (Devices)·Z-0540-2018·Announced 2018-02-14

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.

What this means for you

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 or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 470 cases of Safety-Deluxe Lumbar Puncture Trays, Catalog # 974. The recall is due to the potential presence of loose polypropylene foreign matter above release specifications in the BD SafetyGlide Needle 22GA 1-1/2 inch component.

The affected products were distributed nationwide in the United States. The recall covers eight specific lot numbers with expiration dates ranging from June 2018 to September 2019.

Healthcare facilities and consumers should stop using the affected trays and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
Manufacturer
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Category
Medical Device — Surgical Instruments
Hazard
Affected units
470

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 (8)

  • Lot Number/Expiration Date: 1) 1610300/Expiration Date 03/01/2019
  • 2) 1610503/Expiration Date 05/30/2019
  • 3) 1710059/Expiration Date: 09/30/2019
  • 4) 1610383/Expiration Date: 02/28/2019
  • 5) 1610463/Expiration Date: 05/30/2019
  • 6) 1610215/Expiration Date: 02/01/2019
  • 7) 1610114/Expiration Date: 11/01/2018
  • 8) 1610044/Expiration Date: 06/01/2018

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

Same manufacturer · Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

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Same hazard · foreign matter

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