Z-0190-05

Safety Paracentesis Procedure Tray

Name: Z-0190-05 Safety Paracentesis Procedure Tray
Creator: Merit Medical Systems, Inc
Published: 2004-10-15
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2004-10-15 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of Safety Paracentesis Procedure Tray on 2004-10-15. The reason FDA records is "Merit Safety Paracentesis Procedure Trays contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0190-05
Status: Terminated
Initiated: 2004-10-15
Posted: 2004-11-11
Terminated: 2004-12-15
Recalling firm: Merit Medical Systems, Inc.
Product: Safety Paracentesis Procedure Tray
Product code: DQY Catheter, Percutaneous
Reason for recall: Merit Safety Paracentesis Procedure Trays contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use.
FDA root cause: Other
Action: All consignees were notified by sales reps either by visit or telephone beginning 10/18/2004
Quantity in commerce: 2141 trays
Distribution: Nationwide. No foreign distribution
Product codes and lots: Catalog # SPPT-100, Lot #''s A343633, A344897, A349218. Catalog # SPPT-5F-10, Lot #''s A343629, A343630, A344898, A347256. Catalog # SPPT-5F-7, Lot #''s A343631, A343632, A347254, A349221.

Product code DQY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)