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 MMS

  • 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 MMSsee related information
Date Initiated by FirmFebruary 21, 2005
Date PostedApril 27, 2005
Recall Status1 Terminated 3 on December 20, 2006
Recall NumberZ-0763-05
Recall Event ID 31451
Product Classification Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
ProductMeridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900, 40010-1, and 40111-1. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
Code Information Part Number 15900, 20 per case, Lot Numbers: 571671004;  Part Number 40010-1, 20 per case, Lot Numbers: 568901004, 581081104;  Part Number 40111-1, 20 per case, Lot Numbers: 575701104;  Part Number 40111-13042, 20 per case, Lot Numbers: 564430904, 580031104;  Part Number 60111-1, 20 per case, Lot Numbers: 594870105;  Part Number 60111-1MN, 20 per case, Lot Numbers: 569701004;  Part Number 60211-1304042, 15 per case, Lot Numbers: 591400105 
Recalling Firm/
Manufacturer		 MMS Sales Corp
218 Highline Rd
Pharr TX 78577-9726
Manufacturer Reason
for Recall		Partial occlusion in the T-piece resulting in airway obstruction.
FDA Determined
Cause 2		Other
ActionThe firm initiated the recall on February 21, 2004 by letter to all consignees.
Quantity in CommerceTotal for all products: 7455 cases (161,273 units)
DistributionProduct was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
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.
-
-