Class 2 Device Recall CV Catheter Repair Kit

• Date Initiated by Firm: January 04, 2023
• Date Posted: February 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1051-2023
• Recall Event ID: 91327
• 510(K)Number: K830406 K871998
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: Catalog Number / Product Description; 0601600 2.7F Broviac CV Catheter Repair Kit ; 0601610 4.2 Fr Broviac CV Catheter Repair Kit ; 0601620 6.6F Broviac CV Catheter Repair Kit ; 0601630 9.6F Hickman CV Catheter Repair Kit ; 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F); 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F); 0601700 9F Hickman CV Catheter Repair Kit ; 0601710 12F Hickman CV Catheter Repair Kit ; 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F); 0601740 12.5F Hickman CV Catheter Repair Kit ; 0601750 10F Leonard CV Catheter Repair Kit ; 0601760 7F Hickman CV Catheter Repair Kit ; 0601790 10F Hickman CV Catheter Repair Kit
• Code Information: Catalog Numbers/Lot-Serial Numbers/UDI Code: 0601610 / REFX4541 / (01)00801741036385(17)230930(10)REFX4541 0601610 / REFX5636 / (01)00801741036385(17)240930(10)REFX5636 0601610 / REFY2820 / (01)00801741036385(17)230930(10)REFY2820 0601610 / REGP0198 / (01)00801741036385(17)241231(10)REGP0198 0601610 / REGP2720 / (01)00801741036385(17)250131(10)REGP2720 0601610 / REGQ1144 / (01)00801741036385(17)250228(10)REGQ1144 0601620 / REES0680 / (01)00801741074479(17)230430(10)REES0680 0601620 / REEU0726 / (01)00801741074479(17)230630(10)REEU0726 0601620 / REEU1536 / (01)00801741074479(17)230630(10)REEU1536 0601620 / REEU3300 / (01)00801741074479(17)230630(10)REEU3300 0601620 / REEV1906 / (01)00801741074479(17)230731(10)REEV1906 0601620 / REFX4543 / (01)00801741074479(17)230930(10)REFX4543 0601630 / REEQ0746 / (01)00801741036408(17)230228(10)REEQ0746 0601630 / REGN2382 / (01)00801741036408(17)241231(10)REGN2382 0601630 / REGQ1143 / (01)00801741036408(17)250228(10)REGQ1143 0601680 / REER3749 / (01)00801741036415(17)230331(10)REER3749 0601680 / REEU1626 / (01)00801741036415(17)230630(10)REEU1626 0601690 / REES0716 / (01)00801741036422(17)230131(10)REES0716 0601690 / REFX1172 / (01)00801741036422(17)230131(10)REFX1172 0601690 / REFY0874 / (01)00801741036422(17)230131(10)REFY0874 0601700 / REES2549 / (01)00801741036439(17)230430(10)REES2549 0601700 / REGQ1154 / (01)00801741036439(17)230731(10)REGQ1154 0601710 / REFY2852 / (01)00801741036446(17)231031(10)REFY2852 0601730 / REGQ1174 / (01)00801741036453(17)240229(10)REGQ1174 0601740 / REFZ0223 / (01)00801741036460(17)230930(10)REFZ0223 0601750 / REFY0744 / (01)00801741036477(17)230731(10)REFY0744 0601760 / REEU1534 / (01)00801741036484(17)230630(10)REEU1534 0601790 / REFW1651 / (01)00801741036514(17)231031(10)REFW1651 7741700 / REET0877 / (01)00801741036798(17)240131(10)REET0877 7741800 / REER0703 / (01)00801741036804(17)240531(10)REER0703 7741800 / REFW3156 / (01)00801741036804(17)250131(10)REFW3156 0601600 / REES06790 / (01)00801741036378(17)220831(10)REES0679 0601600 / REES2528 / (01)00801741036378(17)220831(10)REES2528 0601600 / REES3456 / (01)00801741036378(17)220831(10)REES3456 0601610 / REEQ1683 / (01)00801741036385(17)220831(10)REEQ1683 0601610 / REEQ4180 / (01)00801741036385(17)220831(10)REEQ4180 0601610 / REER3748 / (01)00801741036385(17)220831(10)REER3748 0601610 / REES0715 / (01)00801741036385(17)220831(10)REES0715 0601610 / REET3287 / (01)00801741036385(17)220831(10)REET3287 0601620 / REEQ2751 / (01)00801741074479(17)220831(10)REEQ2751 0601620 / REEQ4141 / (01)00801741074479(17)220831(10)REEQ4141 0601620 / REER3694 / (01)00801741074479(17)220831(10)REER3694 0601620 / REET3269 / (01)00801741074479(17)220831(10)REET3269 0601630 / REEU0729 / (01)00801741036408(17)220831(10)REEU0729 0601630 / REEU3297 / (01)00801741036408(17)220831(10)REEU3297 0601690 / REEU0727 / (01)00801741036422(17)220831(10)REEU0727 0601700 / REER3695 / (01)00801741036439(17)220831(10)REER3695 0601710 / REER3750 / (01)00801741036446(17)220831(10)REER3750 0601710 / REEU3314 / (01)00801741036446(17)220831(10)REEU3314 0601740 / REEU3298 / (01)00801741036460(17)220831(10)REEU3298 0601750 / REEU0730 / (01)00801741036477(17)220831(10)REEU0730 0601750 / REEU1608 / (01)00801741036477(17)220831(10)REEU1608 0601760 / REER3696 / (01)00801741036484(17)220831(10)REER3696 0601760 / REES3457 / (01)00801741036484(17)220831(10)REES3457 0601760 / REET2794 / (01)00801741036484(17)220831(10)REET2794 0601760 / REEU1184 / (01)00801741036484(17)220831(10)REEU1184
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: Padraic OBrien; 480-597-8203
• Manufacturer Reason for Recall: Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
• FDA Determined Cause: Under Investigation by firm
• Action: On 01/04/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx or email to customers informing them that the firm has received complaints regarding hardened/coagulated adhesive associated with various Catheter Repair Kits. as a result of the hardened/coagulated adhesive, there is the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained, therefore potentially prolonging surgery or necessitating exchange. Customer are instructed to: 1. Discontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. 3. If customers purchased this product from a distributor, contact the distributor for further instructions and credit resolution. 4. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any applicable credit regarding impacted product. 5. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For Distributors (in addition to the above): Identify all customers within their distribution network that purchased any affected product and provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. Contact their BD representative if they require assistance with this process or they may also contact the number below for further assistance. North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com
• Quantity in Commerce: 7520 (Breakdown: US 3764; OUS 3243)
• Distribution: Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LJS and Original Applicant = CATHETER TECHNOLOGY CORP.; 510(K)s with Product Code = LJS and Original Applicant = EVERMED, INC.