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.
- Affected units
- 80
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:
Part of a larger recall action
This product is one of 2 recalled by Busse Hospital Disposables, Inc. 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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