Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Paracentesis Procedure Tray

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Paracentesis Procedure Traysee related information
Date Initiated by FirmOctober 15, 2004
Date PostedNovember 11, 2004
Recall Status1 Terminated 3 on December 15, 2004
Recall NumberZ-0190-05
Recall Event ID 30343
Product Classification Catheter, Percutaneous - Product Code DQY
ProductSafety Paracentesis Procedure Tray
Code Information 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.
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 West Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer 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 Determined
Cause 2		Other
ActionAll consignees were notified by sales reps either by visit or telephone beginning 10/18/2004
Quantity in Commerce2141 trays
DistributionNationwide. No foreign distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-