The Recall Desk
ModerateFDA (Devices)·Z-1147-2022·Announced 2022-06-08

I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues

Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.

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 precautionary recall initiated due to manufacturing test method validation issues. No illnesses or injuries have been reported, and the recall involves precautionary measures rather than confirmed product defects.

Plain-English summary

Busse Hospital Disposables, Inc. is recalling I.V. Start Kits that contain swab products manufactured by Professional Disposables International (PDI). The recall affects approximately 2,475 units distributed nationwide, including kits with Catalog Number 822.

The recall was initiated because the manufacturer could not adequately validate the test methods used during production of the swab components. This validation gap means the company cannot confirm that all products meet established specifications and quality standards.

Healthcare facilities and consumers who have received these kits should not use them. Contact Busse Hospital Disposables, Inc. for guidance on returning or disposing of affected units. Verify that replacement swabs meet appropriate quality and safety requirements.

For more information, refer to FDA recall number Z-1147-2022 and UDI 00849233010017.

The recalled product

Product
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device — I.V. / Catheter
Hazard
  • manufacturing-validation-failure

Distribution

Distributed nationwide across the United States.

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