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FDA (Device enforcement)Recalled 2022-02-22closedclass ii

Busse Hospital Disposables, Inc.: Port Tray Catalog 7607

Is my product affected?

Port Tray Catalog 7607

  • UPC 00849233014176

Check against the official notice below — it lists the full affected range.

What happened

Busse Hospital Disposables, Inc. is recalling Busse Convenience kits sold nationwide that contain swab or swabstick drug products manufactured by Professional Disposables International (PDI). The recall affects 576 units across multiple lots due to uncertainty about whether the test methods used to manufacture these drug products were adequately validated. The affected lot numbers are 2010357, 2110129, 2110181, 2110225, and 2110252.

The recall notice does not specify what consumers or healthcare facilities should do with affected products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Details from the source

Reason for recall: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products Distribution: Nationwide Quantity: 576 units Lot/code info: Lot Numbers: 2010357 2110129 2110181 2110225 2110252 UDI: 00849233014176

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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