The Recall Desk

FDA (Devices) recall action 63100

Applied Medical Resources Corp recalled 3 products on 2012-10-03

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
2012-10-03
Critical
0
Units
120,714

Why these products were recalled

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

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.

1–3 of 3

  • ModerateFDA (Devices)··2012-10-03

    Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter

    Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.

    Product
    Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-10-03

    Applied Medical Recalls Irrigation Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of irrigation catheters because packaging particulate matter may reside on the product.

    Product
    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascul
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-10-03

    Applied Medical Recalls Vascular Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of Vascular Catheters because packaging particulate matter may reside on the product.

    Product
    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNT
    Category
    Distribution
    0 states