The Recall Desk
ModerateFDA (Devices)·Z-0325-2023·Announced 2022-12-07

3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect

3M is recalling Steri-Drape Surgical Drapes because the liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable.

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: This is an FDA Class II recall involving a manufacturing defect that compromises product functionality. No injuries or illnesses are reported in the source. The hazard is functional (potential product unusability) rather than directly causing harm, warranting Score 2 (Moderate) per the rubric criteria for manufacturing defects with no reported adverse events.

Plain-English summary

3M is recalling Steri-Drape Surgical Drapes due to a manufacturing defect. The liner on the adhesive component is difficult to remove without damaging the product, which may render the drapes unusable for their intended purpose.

Healthcare facilities and medical professionals using these surgical drapes should discontinue use of affected units. Contact 3M for instructions regarding the recall and return of affected products.

The recalled product

Product
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device — Surgical Supplies
Hazard
  • adhesive-defect
  • 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)00849233016712 Lot Number: 2230276

Distribution

Distributed in 1 state:

  • TX

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