*** 1) Cat — Class II medical device recall Z-2193-2013
Terminated recall by Carefusion 2200 Inc, reported 2013-09-18, distributed nationwide. Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing dra
| Recall number | Z-2193-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2013-08-28 |
| Classified | 2013-09-11 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | IS |
| Lot numbers | 548682, 554361 |
| Model numbers | 4341B, 4341BSDF |
| Expiration dates | 2004-04-30, 2013-05-31, 2013-08-31, 2013-09-30, 2013-10-31, 2013-11-30, 2013-12-31, 2014-01-31, 2014-02-28, 2014-03-31, 2014-04-30, 2014-05-31, 2014-06-30, 2014-07-31, 2014-08-31, 2014-09-30, 2014-10-31, 2014-11-30, 2014-12-31, 2015-01-13, 2015-02-28, 2015-03-31, 2015-04-30, 2015-05-31, 2015-07-31 and 16 more |
Product
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.
Reason for recall
Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
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-2193-2013. 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.