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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 Catheter see related information
Date Initiated by Firm September 21, 2004
Date Posted February 18, 2005
Recall Status1 Terminated 3 on May 04, 2005
Recall Number Z-0552-05
Recall Event ID 30089
510(K)Number K930129  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product Arrow 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
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Jody 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
Action The 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 Commerce 25 kits
Distribution The products were shipped to hospitals in AZ, CA, NJ, and WV.
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 = LJS and Original Applicant = ARROW INTL., INC.
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