Thoracentesis & Paracentesis Procedure Tray — Class II medical device recall Z-0566-2015
Terminated recall by Pfm Medical Inc, reported 2014-12-17, distributed nationwide. PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial
| Recall number | Z-0566-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfm Medical Inc, Carlsbad, CA, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, MY |
| Quantity | 75 units |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 1212-001, 1212-034 |
| Model numbers | 850004, M7553 |
Product
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
Reason for recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
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-0566-2015. 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.