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

Busse Hospital Disposables, Inc.: Universal Nerve Block Tray Catalog Number: 9818

Is my product affected?

Universal Nerve Block Tray Catalog Number: 9818

  • UPC 00849233012042

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

What happened

Busse Hospital Disposables is recalling its Universal Nerve Block Tray (Catalog Number 9818) nationwide. The recall affects 60 units distributed across the country. The trays contain swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to a drug recall because there is uncertainty about whether the test methods used to manufacture these products were adequately validated.

The affected lots are 2030783, 2031093, 2130287, 2130412, 2130681, and 2131043. The product has UDI 00849233012042. The source document does not specify what action 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: 2030783 2031093 2130287 2130412 2130681 2131043 UDI:00849233012042

Source

Official record: FDA (Device enforcement) ↗

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

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