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 |
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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.
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510(K) Database | 510(K)s with Product Code = MSD
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