Irrigation Catheters — Class II medical device recall Z-2448-2012
Terminated recall by Applied Medical Resources Corp, reported 2012-10-03, distributed nationwide. Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential
| Recall number | Z-2448-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-09-25 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, DE, EC, EE, ES, FR, GB, HK, IE, IL, IT, KR, MY, NL, NZ, PK, PL, PT, QA, RS, SA, TW, ZA |
| Quantity | 40,238 units |
| Reason classes | specification failure |
| Lot numbers | 1156082, 1158230, 1158960, 1164648, 1170185, IRR-023-10F, IRR-080-4F, IRR-080-6F |
| Model numbers | 1156082, 1158230, 1158960, 1164648, 1170185, IRR-023-10F, IRR-080-4F, IRR-080-6F |
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 vascular system and biliary tree.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2448-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.