Single Lumen Pressure Monitoring Sets and Trays The subject sets and… — Class I medical device recall Z-0800-2016
Terminated recall by Cook Inc., reported 2016-03-02, distributed nationwide. A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may incl
| Recall number | Z-0800-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2016-01-06 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, DE, DO, IL, PA |
| Quantity | 2,280 |
| Reason classes | device malfunction |
| Lot numbers | 5803601, 5828147, 5889463, 5898283, 5906417, 5922849, 5941909, 5941919, 5964565, 5976506, 6021072, 6028497, 6028502, 6034979, 6034985, 6067668, 6075213, 6083984, 6143834, 6148788, 6160213, 6160238, 6194848, 6254047, NS5833882, NS5892109, NS5892110, NS5919920, NS5932835, NS5932836, NS5933957, NS6014456, NS6014457, NS6014458, NS6014483, NS6021136, NS6050233, NS6054843, NS6064797, NS6072523 and 10 more |
| Model numbers | 5803601, 5828147, 5889463, 5898283, 5906417, 5922849, 5941909, 5941919, 5964565, 5976506, 6021072, 6028497, 6028502, 6034979, 6034985, 6067668, 6075213, 6083984, 6143834, 6148788, 6160213, 6160238, 6194848, 6254047, C-PMS-250 and 38 more |
Product
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Reason for recall
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
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-0800-2016. 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.