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U.S. Department of Health and Human Services

Class 2 Device Recall Large Bore Central Venous Catheters

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 Class 2 Device Recall Large Bore Central Venous Catheterssee related information
Date Initiated by FirmMay 08, 2009
Date PostedAugust 10, 2009
Recall Status1 Terminated 3 on July 29, 2010
Recall NumberZ-1671-2009
Recall Event ID 52376
510(K)NumberK970864 
Product Classification Central Venous Catheters - Product Code FOZ
Product12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
Code Information Product number AK-12123-H - Lot numbers: RF8045004, RF8072289, RF8084254, RF8107640, RF8108841, RF8110482, RF8122717, RF9027113, RF9030981; Product number CS-12123-E - Lot numbers: RF8032041, RF8043417, RF8058142, RF8060023, RF8072220, RF8084333, RF8097145, RF8109080, RF8110116, RF9015982, ZF7126427, ZF8027168, ZF8027448, ZF8037862, ZF8048194, ZF8048672, ZF8059197, ZF8069577, ZF8090983, ZF8091196, ZF8101854, ZF8102010, ZF8112852, ZF8124161, ZF9014366, ZF9025408, ZF9035840, ZF9046856; Product number MA-12123 - Lot numbers: ZF8027407, ZF8059146, ZF8090984, ZF9014354, ZF9046854; and  Product number MC-12123 - Lot numbers: RF8057141 and RF8083743.
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information ContactCustomer Service
800-523-8446
Manufacturer Reason
for Recall		Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.
Quantity in Commerce46,610 total
DistributionWorldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
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 = FOZ
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