The Recall Desk
HighFDA (Devices)·Z-1152-2022·Announced 2022-06-08

Busse Single Shot Epidural Tray recalled for test method validation uncertainty

Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The hazard involves validation uncertainty for test methods used in quality control for a medical device applied to critical procedures. This constitutes a risk-of-harm product without reported injury, meeting the High severity threshold per the rubric.

Plain-English summary

Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Tray (Catalog 1292) distributed nationwide.

The product contains swab/swabstick components manufactured by Professional Disposables International (PDI). The recall was issued due to uncertainty regarding the adequacy of the validation of test methods used to manufacture these components.

The FDA classified this as a Class II recall. Affected lot numbers are 2130282, 2130576, and 2131060 (UDI: 00849233003644).

The recalled product

Product
Single Shot Epidural Tray Catalog 1292
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device — Surgical Equipment
Hazard
  • validation-uncertainty

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)

  • Lot Numbers: 2130282 2130576 2131060 UDI: 00849233003644

Distribution

Distributed nationwide across the United States.

Related recalls

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