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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter

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 Class 2 Device Recall Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Cathetersee related information
Date Initiated by FirmSeptember 21, 2004
Date PostedFebruary 18, 2005
Recall Status1 Terminated 3 on May 04, 2005
Recall NumberZ-0552-05
Recall Event ID 30089
510(K)NumberK930129 
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
ProductArrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW
Code Information Lot numbers RF4088611 and RF4088128
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactJody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall		Product was mislabeled for lumen configuration, flow rates, and priming volume.
FDA Determined
Cause 2		Other
ActionThe recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals.
Quantity in Commerce25 kits
DistributionThe products were shipped to hospitals in AZ, CA, NJ, and WV.
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 = LJS
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