Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Catheterization Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Catheterization Kit see related information
Date Initiated by Firm January 09, 2015
Date Posted January 29, 2015
Recall Status1 Terminated 3 on August 23, 2017
Recall Number Z-1030-2015
Recall Event ID 70313
510(K)Number K121941  K122545  
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
Product Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Code Information Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS,   ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A,   ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A ,   CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120 
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall		 Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
FDA Determined
Cause 2		 Packaging process control
Action Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.
Quantity in Commerce 4484
Distribution US (nationwide) and PR.
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 = OBJ and Original Applicant = ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
-
-