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U.S. Department of Health and Human Services

Class 2 Device Recall MMS

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  Class 2 Device Recall MMS see related information
Date Initiated by Firm February 21, 2005
Date Posted April 27, 2005
Recall Status1 Terminated 3 on December 20, 2006
Recall Number Z-0760-05
Recall Event ID 31451
Product Classification Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
Product Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
Code Information Item Number 15867, 15 per case, Lot numbers: 562960904; 566590904;  Item Number 15880, 15 per case, Lot numbers: 564360904, 566230904, 570181004, 571831004, 573201004, 573201004, 575401104, 575401104, 577011104, 577011104, 578951104, 581731104, 582631204, 588431204, 588431204, 589090105, 591180105, 591180105, 593360105, 596220105, 596220105, 597890105, 597890105;  Item Number 12000-1, 7 per case, Lot Numbers: 581041104;  Item Number 15880-30, 15 per case, Lot Numbers: 573401004;  Item Number 40000-1, 20 per case, Lot Numbers: 568891004, 571691004, 581071104, 585381204, 589170105, 591260105, 593990105, 594930105;  Item Number 40200-1, 20 per case, Lot Numbers: 573461004, 573771004, 579661104;  Item Number 40301-1, 20 per case, Lot Numbers: 584241204;  Item Number 40301-1-13, 20 per case, Lot Numbers: 566290904, 569631004, 572811004, 574881104, 574881104, 578021104, 579671104, 585121204, 586721204, 588541204, 591330105, 593810105, 593810105;  Item Number 40301-1-13MM, 20 per case, Lot Numbers: 569211004, 583381204;  Item Number 40301-1-24, 20 per case, Lot Numbers: 564930904, 566300904, 571471004, 572821004, 574891104, 578081104, 580591104, 581691104, 583391204, 586731204, 588551204, 598410105;  Item Number 40301-1-30, 20 per case, Lot Numbers: 570781004, 593640105;  Item Number 40301-1ML, 20 per case, Lot Numbers: 574901104, 594840105;  Item Number 40302-1C24, 20 per case, Lot Numbers: 562980904, 566650904, 570791004;  Item Number 60000-1, 15 per case, Lot Numbers: 591360105;  Item Number 60201-1, 15 per case, Lot Numbers: 566370904, 568921004, 572491004, 573991004, 579691104, 581721104, 586761204, 590200105, 593860105, 595720105;  Item Number 60300-1, 15 per case, Lot Numbers: 594760105;  Item Number 60300-M, 15 per case, Lot Numbers: 568501004, 575711104;  Item Number 60301-1-24, 15 per case, Lot Numbers: 581731104;   Item Number 60301-13042M, 15 per case, Lot Numbers: 564510904, 568511004, 571951004, 573311004, 577181104, 580111104, 584431204, 586601204, 588621204, 589360105, 593490105, 596320105;   Item Number 60302-1HM30-70, 15 per case, Lot Numbers: 565830904, 581791104, 585661204, 589370105, 590210105;  Item Number 72000-50-7589, 15 per case, Lot Numbers: 583451204;  Item Number 72000-75, 15 per case, Lot Numbers: 568521004, 571511004, 571961004, 574971104, 577191104, 578131104, 578131104, 582761204, 584961204, 593870105;  Item Number 72300-1-4-30-70, 15 per case, Lot Numbers: 564950904, 567821004, 572841004, 578141104, 580621104, 583471204, 586771204, 589380105, 591430105, 593880105, 597180105;  Item Number 72301-1, 15 per case, 594880105;   Item Number C4N000D001, 20 per case, 568751004, 574801104, 578781104, 586301204, 591060105, 593660105, 595620105, 596830105, 596950105  Item Number 60301-1304042, 15 per case, Lot Number 597570105
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
Action The firm initiated the recall on February 21, 2004 by letter to all consignees.
Quantity in Commerce Total for all products: 7455 cases (161,273 units)
Distribution Product 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 Cycle TPLC 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.
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