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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW, ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUADLUMEN CVC KIT

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  Class 2 Device Recall ARROW, ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUADLUMEN CVC KIT see related information
Date Initiated by Firm June 02, 2016
Date Posted July 06, 2016
Recall Status1 Terminated 3 on August 25, 2017
Recall Number Z-2136-2016
Recall Event ID 74362
510(K)Number K071538  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER.

Product Usage:
Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.
Code Information Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Alice Harper
610-378-0131
Manufacturer Reason
for Recall		 Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
FDA Determined
Cause 2		 Process control
Action Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.
Quantity in Commerce 1, 170 units
Distribution US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
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.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTERNATIONAL, INC.
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