The Recall Desk

FDA (Devices) recall action 95613

Advanced Medical Solutions Ltd. recalled 3 products on 2024-12-11

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2024-12-11
Critical
0
Units
13,700

Why these products were recalled

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

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

1–3 of 3

  • HighFDA (Devices)··2024-12-11

    McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect

    McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.

    Product
    McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2024-12-11

    Hollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect

    Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.

    Product
    Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2024-12-11

    Medline MaxOrb Extra Alginate Wound Dressing Recalled for Packaging Defect

    Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch that compromise sterile barrier integrity. Products affected were distributed in Illinois, Texas, and Virginia.

    Product
    MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds
    Category
    Distribution
    3 states