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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Intl PICC Kits with PeelAway Sheath Component

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  Class 2 Device Recall Arrow Intl PICC Kits with PeelAway Sheath Component see related information
Date Initiated by Firm July 30, 2015
Date Posted August 25, 2015
Recall Status1 Terminated 3 on June 28, 2018
Recall Number Z-2462-2015
Recall Event ID 71854
510(K)Number K042126  K061289  K073451  K103255  K103658  K121941  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound

Product Usage:
catheter, intravascular, therapeutic, ultrasound
Code Information Product Codes: ASK-02041-SEH1 CA-05052-HP CDC-34052-VPS EU-05552-HPMSB ASK-04001-DU4   CA-05052-HPX CDC-35041-VPS FR-04041 ASK-04052-AC CDC-02041-MK1A CDC-35052-VPS FR-04041-CF ASK-05041-LM4   CDC-04041-HPK1A CDC-35541-VPS FR-05041 ASK-05052-SFL CDC-04052-HPK1A CDC-35552-VPS FR-05041-CF ASK-05541-MS2   CDC-05041-HPK1A EU-04041-HP FR-05541-CF ASK-05541-MS3  CDC-05052-HPK1A EU-04041-HPMSB PI-01451-LS ASK-15552-LM2 CDC-05541-HPK1A  EU-04052-HPMSB PI-01451-LS5 ASK-15552-MS3 CDC-05542-PK1A EU-05041-HPMSB PK-01451-WS ASK-35041-JHVA CDC-05552-HPK1A EU-05052-HPMSB PK-01451-WSSP CA-05041-HP  CDC-15552-HPK1A EU-05541-HP UK-05041-HPMIN CA-05041-HPX CDC-34041-VPS   EU-05541-HPMSB  lot numbers: 23F14H0517 23F14J0077 23F15F0662 71F14M0678 71F15A1660 23F14L0941 23F15C2282 23F14H0328 71F15A0395 71F15B1938 23F14B1232 23F14D0456 23F14C0598 71F15C0214 71F15D0235 23F15A1523 23F14C0059 23F14F1505 71F15D0053 71F14L1345 23F14A1779 23F14E1213 23F14K1025 71F15D1075 71F15D1077 23F14G1295 23F14G1470 23F15B0400 23F14C0576 71F15E0455 23F14J0973 23F14H1111 23F14F1507 23F14F0115 71F14K1571 23F14M0791 23F14J0613 23F14M0440 23F14G1130 71F14F1786 23F15A1171 23F15A0149 23F14F0364 23F14F0504 71F14G1690 23F14H0848 23F15D0507 23F14L0838 23F14D0713 71F14F1844 23F14F0370 23F14J1512 23F14H0331 23F14C0575 71F14E2043 23F15C2435 23F15C0302 23F15B0401 23F14D0724 71F14K0639 23F14L0090 23F15B0399 23F15D0938 23F14E1493 71F15B1937 23F14G1072 23F14C1096 23F15D0313 23F14F0716 71F14L0577 23F14M0774 23F14H1112 23F14D0281 23F14M1010 71F14L1347 23F15D0622 23F14C0640 23F14E1325 23F15D1420 71F15A1302 23F14H0920 23F14F1497 23F14G0091 71F14H0351 71F15B0662 23F14J1382 23F15A1857 23F14D0282 71F14H0947 71F15D0681 23F15A0038 23F15D0830 23F14H0498 71F14G0365 71F14J1860 23F15C1236 23F14G1471 23F14H1312 71F14H1396 71F14F1785 23F14E1373 23F14M0038 23F14D0285 71F14J0869 71F15A0300 23F14E1124 23F14J1312 23F14B1144 71F14K0082 71F15C2011 23F14F0441 23F15A1604 23F14G0095 71F14F1358 23F14J0437 23F14G1226 23F15B2002 23F14H1314 71F14K0622 23F14K0406 23F15B0065 23F15E1025 23F14E1469 71F14K1332 23F14B0935 23F14J1546 23F14A1419 23F14E1261 71F15A1289 23F14H1535 23F14L0882 23F14C0643 23F14J1390 71F15C1137 23F15A0278 23F15C1237 23F14F1504 23F14E1262 71F15A1984 23F15D0907 23F14H0301 23F14J0221 23F14H0510 71F15B0638 23F14F0326 23F14E1093 23F14J1513 23F14B1128 71F15D0272 23F14K1016 23F14J0415 23F14L1144 23F14C0473 71F15A0152 23F14G1587 23F14B0844 23F14E0791 23F14D0308 71F14M0141 23F15A1813 23F14L0810 23F14E0406 23F14J1391 71F15D1059 23F14D0042 23F14K1361 23F14E1215 23F14F0780 23F14D0217 23F15D0284 23F14M0484 23F14G1458 23F14H0512 23F14D1125 23F14J0358 23F14L0187 23F15D1232 71F14K0081 23F14B1013 23F14F0106 23F15D0881 23F14J0617 71F14J1087 23F14F0510 23F15A0388 23F14J1048 23F14K0537 71F14K0628 71F14K1569 23F15D0046 23F14J0076 23F15A0695 71F14L0323 71F15D0052 71F14G0670 23F15D0882 23F14L1146 71F15D0234 71F14J1086 71F14K1035 23F15F0193 23F15C0992 71F14L0762 71F14H0374 71F14K0409 23F15A0691 71F15B0648 71F14K1198 71F14L1351     
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall		 the catheter peel-away component hub tabs may prematurely detach. One injury reported.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Teleflex sent an Urgent Medical Device Recall Notificatin letters dated July 30, 2015 to their affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. immediately discontinue use and quarantine any products with the catalog and lot number provided in the notice. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. Customers were also asked to complete the enclosed Recall Acknowledgment Form if there is no affected product, this will allow for documented receipt of this letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 52109
Distribution US Nationwide Distribution and internationally to Canada
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 INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
510(K)s with Product Code = LJS and Original Applicant = ARROW INTERNATIONAL, INC.
510(K)s with Product Code = LJS and Original Applicant = ARROW INTL., INC.
510(K)s with Product Code = LJS and Original Applicant = TELEFLEX, INC.
510(K)s with Product Code = LJS and Original Applicant = VASONOVA INC.
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