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U.S. Department of Health and Human Services

Class 2 Device Recall MRVLS 4W GXL: W1/R RBLS

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 Class 2 Device Recall MRVLS 4W GXL: W1/R RBLSsee related information
Date Initiated by FirmJuly 19, 2015
Date PostedSeptember 10, 2015
Recall Status1 Terminated 3 on September 18, 2017
Recall NumberZ-2749-2015
Recall Event ID 71880
510(K)NumberK122953 
Product Classification Pump, infusion, insulin - Product Code LZG
ProductElcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
Code Information Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401  Elcam Part Number: 470307; lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901  Elcam Part Number: 471601; lot numbers: 1270239001, 1370266601, 1370271501, 1370278801  Elcam Part Number: 471604; lot numbers: 147029310, 1470306801, 1470310201, 1470312501  Elcam Part Number: 477101; lot numbers: 1270244201, 1370278901, 1470292401, 1470292402, 1470298901, 1470301301, 1470306901, 1470310101, 1470312601  Elcam Part Number: 477102; lot numbers: 1370261201, 1570323201  Elcam Part Number: 477901; lot number: 1370255601  Elcam Part Number: 477904; lot number: 1470300101  Elcam Part Number: 478003; lot numbers: 1370261401, 1370266701, 1370271701, 1370271702, 1370278601, 1370278602, 1470293201, 1470296001, 1470307001, 1470312701, 1570316201  Elcam Part Number: 478004; lot numbers: 1370255001, 1370261501, 1370271801, 1370279001, 1470296101, 1470297801, 1470303801, 1470307101, 1470312801  Elcam Part Number: 478701; lot numbers: 1270244901, 1370261301, 1370271901  Elcam Part Number: 478704; lot numbers: 1470296201, 1470299101, 470307201, 1470312901  
Recalling Firm/
Manufacturer		 Elcam Medical, Inc.
2 University Plz Ste 620
Hackensack NJ 07601-6224
For Additional Information ContactMs. Miriam Lerner
201-457-1120
Manufacturer Reason
for Recall		Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
FDA Determined
Cause 2		Packaging
ActionElcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.
Quantity in Commerce248,100
DistributionTexas, New Mexico and Pennsylvania
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.
510(K) Database510(K)s with Product Code = LZG
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