The Recall Desk
ModerateFDA (Devices)·Z-2446-2012·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential packaging particulate matter without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Applied Medical Resources Corp is recalling specific lot numbers of its Vascular Catheters, including Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX). The recall involves 40,238 units distributed nationwide in the United States and in 29 other countries.

The recall was initiated because the devices may have a potential for packaging particulate matter to reside on the product. These catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system and consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

Healthcare facilities and distributors should check their inventory for the specific model and lot numbers listed in the recall notice. The source text does not provide specific consumer instructions or report any illnesses or injuries associated with this recall.

The recalled 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
Manufacturer
Applied Medical Resources Corp
Category
Medical Device — Vascular Catheters
Hazard
Affected units
40,238

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Numbers: Lot Numbers A4402: 1157054
  • 1163804
  • 1170473. A4403: 1157060
  • 1162689
  • 1166031
  • 1169109. A4404: 1160223
  • 1163803
  • 1166725
  • 1171181. A4405: 1155214
  • 1157053
  • 1161472
  • 1162967
  • 1164628
  • 1168912. A4406: 1155428
  • 1162945
  • 1167745
  • 1170042. A4407: 1154478
  • 1162866
  • 1168604. A4408: 1163626. A4F00: 1164152
  • 1164627

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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