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

Busse Hospital Disposables, Inc.: MBB Tray Catalog Number: 9882

Is my product affected?

MBB Tray Catalog Number: 9882

  • UPC 00849233000179

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

What happened

Busse Hospital Disposables is recalling MBB Trays (Catalog Number 9882) that contain swab and swabstick drug products manufactured by Professional Disposables International. The recall was initiated because there is uncertainty about whether the test methods used to manufacture these drug products were properly validated. The affected product was distributed nationwide, with 60 units involved in the recall. The recalled items are identified by Lot Numbers 2130220, 2130445, and 2131063, with UDI 00849233000179.

The source document does not specify what actions affected consumers should take regarding this recall.

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: 60 units Lot/code info: Lot Numbers: Lot 2130220 2130445 2131063 UDI: 00849233000179

Source

Official record: FDA (Device enforcement) ↗

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

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