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U.S. Department of Health and Human Services

Class 2 Device Recall EQUISTREAM LongTerm Hemodialysis Catheter

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  Class 2 Device Recall EQUISTREAM LongTerm Hemodialysis Catheter see related information
Date Initiated by Firm May 31, 2019
Create Date August 26, 2019
Recall Status1 Terminated 3 on May 17, 2022
Recall Number Z-2374-2019
Recall Event ID 83337
510(K)Number K090101  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
Code Information Lot # REDN2376 Exp. 9/30/2020 
Recalling Firm/
Manufacturer
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact BPV Customer Support Center
800-321-4254 Ext. 5
Manufacturer Reason
for Recall
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Bard Peripheral Vascular, Inc. (BPV) mailed a recall letter on May 23, 2019 to each of the US consignees via FedEx with proof of delivery notification. BPV is also issuing customer notifications for product outside the US in accordance with regulations of each country in which the product was distributed. The recall letter asked consignees to do the following: 1. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from your shelves. 4. If you have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Please call our BPV Customer Support Center at 1-800-321-4254 Option #5 (M-F 5am to 2pm MST) or email at BDPI.CustomerSupportCenter@bd.com. Once all information has been verified, the BPV Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. BPV will issue a replacemnt product for your returned product. 7. Email the completed Recall and Effectiveness Check Form to BDPI.CustomerSupportCenter@bd.com or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call the BPV Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing labe
Quantity in Commerce 13 units
Distribution US: 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, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY OUS: Australia, 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 = MSD and Original Applicant = C.R. BARD, INC.
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