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U.S. Department of Health and Human Services

Class 2 Device Recall American Access; Nikkiso; Lifeline

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 Class 2 Device Recall American Access; Nikkiso; Lifelinesee related information
Date Initiated by FirmJuly 12, 2018
Create DateAugust 25, 2018
Recall Status1 Terminated 3 on July 02, 2020
Recall NumberZ-2937-2018
Recall Event ID 80581
510(K)NumberK842416 K983511 
Product Classification Catheter, hemodialysis, non-implanted - Product Code MPB
ProductDuo-Flow XTP Straight Full Set, RMS02105 RMS02108
Code Information MKAC440 MCCH440 
FEI Number 2518902
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information ContactCustomer Service
215-256-4201
Manufacturer Reason
for Recall		The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
FDA Determined
Cause 2		Process control
ActionOn July 12, 2018, the firm sent a Product Recall letter to its customers. Customers were provided with a full list of product codes and lot numbers and informed that those items had been recalled due to a potential for the suture wings to crack or break. Customers were informed that implanted catheters with intact suture wings do not need to be removed. However, an alternative method of catheter securement should be initiated for all implanted catheters, due to the potential for the suture wings to crack or break. Customers were instructed to return all unused recalled product to Medcomp. If product was further distributed, customers were asked to notify their sub-accounts. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The phone number to call is 215-256-4201. Customers are asked to complete and return a customer response form included with the recall letter by fax (215-256-9191) or email (complaints@medcompnet.com).
DistributionNationwide distribution; worldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MPB
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