NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended… — Class II medical device recall Z-0848-2013
Terminated recall by Codman & Shurtleff, Inc., reported 2013-02-27, distributed nationwide. Sterility of device may be compromised due to lack of package integrity
| Recall number | Z-0848-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2013-01-11 |
| Classified | 2013-02-20 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CL, CZ, DE, DK, ES, FR, GB, IE, IT, LT, MY, NL, NO, NZ, PL, PT, SG, SK |
| Quantity | 273 units |
| Reason classes | sterility, packaging |
Product
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Reason for recall
Sterility of device may be compromised due to lack of package integrity
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-0848-2013. 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.