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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard involves potential packaging particulate matter, which is a quality control issue without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Applied Medical Resources Corp is recalling specific lot numbers of its irrigation catheters. The recall involves models IRR-023-10F, IRR-080-4F, and IRR-080-6F. These devices are indicated for irrigation in the peripheral vascular system and biliary tree.
The recall is being conducted because the catheters may have a potential for packaging particulate matter to reside on the product. A total of 40,238 units are affected by this recall event.
The affected products were distributed worldwide, including in the United States and numerous international countries. Specific lot numbers are identified for each model in the recall documentation. Healthcare providers and facilities should check their inventory for these specific model and lot numbers.
The recalled 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…
- Manufacturer
- Applied Medical Resources Corp
- Category
- Medical Device — 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 (3)
- Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082
- 1170185
- 1164648. IRR-080-6F: 1158960.
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.
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