Class 2 Device Recall MAHURKAR" and Argyle" acute hemodialysis catheters

• Date Initiated by Firm: April 29, 2019
• Create Date: July 09, 2019
• Recall Status: Terminated on January 09, 2024
• Recall Number: Z-1955-2019
• Recall Event ID: 82802
• 510(K)Number: K893188 K020089 K030209 K092797 K102605
• Product Classification: Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
• Product: MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009; 8813793013; 8813794005; 8813794009; 8813816005; 8813816009; 8813817005; 8813817009; 8815668007; 8815668011; 8815668021; 8815668027; 8817142005; 8817143005; 8817145005; 8817146001; 8817146007; 8817149007; 8817232018; 8817232019; 8817277007; 8817277011; 8817277021; 8817277027; 8830414001; 8830414002; 8830415001; 8830415003; 8830416001; 8830416003; 8830416021; 8830416023; 8831173010; 8831173011; 8831173012; 8831661001; 8831662001; 8831663001; 8831663002; 8831663021; 8831663022; 8832539001; 8832539002; 8832539003; 8832539006; 8832539007; 8888115132; 8888115133; 8888115162; 8888115163; 8888115192; 8888115193; 8888115242; 8888115243; 8888135131; 8888135132; 8888135133; 8888135134; 8888135135; 8888135136; 8888135137; 8888135138; 8888135139; 8888135140; 8888135141; 8888135142; 8888135161; 8888135162; 8888135163; 8888135164; 8888135165; 8888135166; 8888135167; 8888135168; 8888135191; 8888135192; 8888135193; 8888135194; 8888135195; 8888135196; 8888135197; 8888135198; 8888135241; 8888135242; 8888135243; 8888135244; 8888135245; 8888135246; 8888135247; 8888135248; 8888340629; 8888340637; 8888345504; 8888345512; 8888345520; 8888345538; 8888345603; 8888345611; 8888345629; 8888345637; 8888101001HP; 8888101002HP; 8888101003HP; 8888101004HP; 8888102003HP; 8888102004HP; 8888103001HP; 8888103002HP; 8888103003HP; 8888103004HP; 8888104003HP; 8888104004HP; 8888340629HP; 8888340637HP; 8888345504HP; 8888345512HP; 8888345520HP; 8888345538HP; 8888345603HP; 8888345611HP; 8888345629HP; 8888345637HP
• Code Information: All lots
• Recalling Firm/ Manufacturer: COVIDIEN LLC; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Quality Assurance; 508-261-8000
• Manufacturer Reason for Recall: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
• FDA Determined Cause: Error in labeling
• Action: On April 29, 2019, consignees were notified by letter via Federal Express and/or federal mail. The Field Safety Alert informed customers that the priming volume values printed on the MAHURKAR and Argyle acute catheters and Instructions for Use are higher than the volumes required to fill each lumen. The firm will update the IFU for the affected products to provide clarity on the printed priming volumes. In the meantime, the firm recommends the use of a non-heparinized lock solution, such as 4% sodium citrate or 1000 U/mL heparin to mitigate potential risk associated with unintended administration of additional concentrated heparin. The firm asks that customers complete and return the acknowledgement form accompanying the notification even if they do not have affected inventory. If you have experienced quality problems or adverse events, you may contact the firm at quality.assurance@covidien.com.
• Quantity in Commerce: 2,223,067
• Distribution: Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong.
• 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 = NIE and Original Applicant = COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA; 510(K)s with Product Code = NIE and Original Applicant = KENDALL; 510(K)s with Product Code = NIE and Original Applicant = QUINTON, INC.; 510(K)s with Product Code = NIE and Original Applicant = THE KENDALL COMPANY