The Recall Desk
ModerateFDA (Devices)·Z-0326-2023·Announced 2022-12-07

Surgical Injection Tray Recalled Due to Adhesive Liner Defect

Busse Hospital Disposables is recalling 40 cases of Busse Spine Injection Trays containing 3M Steri-Drape Surgical Drapes distributed in Texas due to a defective adhesive liner that is difficult to remove without damaging the product.

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: FDA Class II recall with no reported illnesses or injuries. The defect affects product usability but does not establish an explicit patient safety risk based on information stated in the source text.

Plain-English summary

Busse Hospital Disposables, Inc. is recalling the Busse SPINE INJECTION TRAY (Reference No. 8563R1), a surgical tray designed for spine injections and nerve blocks. The recall involves 40 cases distributed in Texas.

The product contains 3M Steri-Drape Surgical Drapes. The adhesive component has a liner that is difficult to remove without damaging the product, which may render the tray unusable for its intended purpose.

Healthcare facilities and providers in the affected distribution area should verify whether they have inventory matching the recalled lot number (Lot 2230458, UDI-DI: 00849233016705).

If you have received this product, contact Busse Hospital Disposables, Inc. for replacement or return instructions.

The recalled product

Product
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Manufacturer
Busse Hospital Disposables, Inc.
Hazard
  • adhesive-liner-defect
  • product-usability-defect

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 (1)

  • UDI-DI: (01) 00849233016705 Lot Number: 2230458

Distribution

Distributed in 1 state:

  • TX