Recalls / —
—#35696
Product
Safety Paracentesis Procedure Tray
- FDA product code
- DQY — Catheter, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- 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.
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
All consignees were notified by sales reps either by visit or telephone beginning 10/18/2004
Recalling firm
- Firm
- Merit Medical Systems, Inc
- Address
- 1600 West Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- Distribution pattern
- Nationwide. No foreign distribution
Timeline
- Recall initiated
- 2004-10-15
- Posted by FDA
- 2004-11-11
- Terminated
- 2004-12-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #35696. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.