The Recall Desk

FDA (Devices) recall action 68129

Hospira Inc. recalled 5 products on 2014-05-28

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-05-28
Critical
0
Units
1,853,021

Why these products were recalled

The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea

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.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2014-05-28

    Hospira Recalls Cystoscopy Sets Due to Potential Sterile Package Seal Defect

    Hospira Inc. is recalling specific cystoscopy and irrigation sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-05-28

    Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect

    Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.

    Product
    LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-05-28

    Hospira Recalls Latex-Free Extension Sets Due to Packaging Seal Defect

    Hospira is recalling specific latex-free extension sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-05-28

    Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect

    Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-05-28

    Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect

    Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
    Category
    Distribution
    51 states