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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 MMSsee related information
Date Initiated by FirmFebruary 21, 2005
Date PostedApril 27, 2005
Recall Status1 Terminated 3 on December 20, 2006
Recall NumberZ-0766-05
Recall Event ID 31451
Product Classification Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
ProductCircuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and 40301-1-2730. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
Code Information Part Number C4N0121000, 40 per case, Lot Number: 587021204, 587031204, 588371204, 591070105, 596840105;  Part Number N4A100CE06, 20 per case, Lot Number: 575741104;  Part Number N7A110CG06, 15 per case, Lot Number: 596700105;  Part Number 40301-1-2730, 20 per case, Lot Number: 564460904, 566310904, 568481004, 570271004, 571911004, 573261004, 577091104, 580061104, 582711204, 588561204, 589270105, 596290105;  Part Number 60010-1B, 60 per case, Lot Number: 575691104, 579871104, 585041204, 586291204 
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.
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