FDA (Devices) recall action 90072
The FDA (Devices) publishes a recall like this one as 58 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 58 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
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.
Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.
Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.
Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding the adequacy of manufacturing test method validation.
Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
Busse Convenience kits containing medical swabs and sticks have been recalled due to uncertainty about whether the manufacturing test methods used were adequately validated.
Busse Hospital Disposables is recalling convenience kits containing swab products due to uncertainty about adequate validation of manufacturing test methods.
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.
Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.
Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
Busse Hospital Disposables is recalling its SS 4.5MM Pellet Insertion Tray nationwide due to uncertainty regarding the adequacy of the validation of the manufacturing test methods used.
Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.
Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.
Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.