Biliary Catheters — Class II medical device recall Z-2447-2012
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-2447-2012 |
|---|---|
| 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 | 1155852, 1156762, 1164305, 1164306, 1164350, 1165670, 1165674, A4752, A4754, A4762, CB052308, CB054008, CB062313 |
| Model numbers | 1155852, 1156762, 1164305, 1164306, 1164350, 1165670, 1165674, A4752, A4754, A4762, A47XX, CB052308, CB054008, CB062313, CB0XXXXX |
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; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
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-2447-2012. 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.