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U.S. Department of Health and Human Services

Class 2 Device Recall Split Cath III

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  Class 2 Device Recall Split Cath III see related information
Date Initiated by Firm August 04, 2014
Date Posted September 04, 2014
Recall Status1 Terminated 3 on December 10, 2014
Recall Number Z-2592-2014
Recall Event ID 68993
510(K)Number K121848  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product Split Cath III Trays, 16F x 28CM


Product Usage:
The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
Code Information TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017.
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact Customer Support
215-256-4201
Manufacturer Reason
for Recall		 The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Medcomp sent a Recall Notification letter, dated August 4, 2014, to all affected customers. The letter identified the affected product, problem, and action to be taken. Customers were requested to respond and return all affected product. For questions call contact Susan Smith at ssmith@medcompnet.com.
Quantity in Commerce 110
Distribution USA Nationwide Distribution
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 = MEDICAL COMPONENTS INC
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