The Recall Desk

FDA (Devices) recall action 90072

Busse Hospital Disposables, Inc. recalled 58 products on 2022-06-08

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.

Products
58
Announced
2022-06-08
Critical
0
Units
15,650

Why these products were recalled

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.

26–50 of 58

  • ModerateFDA (Devices)··2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed nationwide.

    Product
    SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    Product
    Single Shot Epidural Tray Catalog 1292
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty

    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.

    Product
    Epidural Tray Catalog 1307
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Cervical Tray Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.

    Product
    Cervical Tray Catalog Number: 3765R2
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty

    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.

    Product
    CVC Dressing Change Kit Catalog Number: 2491R1
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Drug Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B7345R1
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues

    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.

    Product
    I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.

    Product
    Epidural Tray Catalog 1577
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    FDA Recalls Swab Products for Manufacturing Validation Uncertainty

    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.

    Product
    SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    Convenience Kits With Swab Drug Products Recalled for Test Validation Failure

    Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    FDA Recalls Pellet Insertion Trays Due to Validation Method Uncertainty

    Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B9743
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Busse Convenience Kit Swab Products Recalled for Test Method Validation Issues

    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.

    Product
    SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    Epidural Tray Recalled Due to Manufacturing Validation Uncertainty

    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.

    Product
    Single Shot Epidural Tray Catalog Number: 6183R1
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Swab and Swabstick Drug Products Recalled Due to Validation Uncertainty

    Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.

    Product
    "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Busse Convenience Kits Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Pellet Insertion Tray Recall for Uncertain Manufacturing Test 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.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-06-08

    Busse Pellet Insertion Tray Kits Recalled for Manufacturing Validation Issues

    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.

    Product
    4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-06-08

    Cervical Tray Catalog 1089 Recalled for Manufacturing Test Method Validation

    Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Cervical Tray Catalog 1089
    Category
    Distribution
    0 states