Recall Z-2592-2014 ยท MSD Catheter, Hemodialysis, Implanted
Medical Components, Inc dba MedComp
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.
| Date | Sep 4, 2014 (initiated Aug 4, 2014) |
| Status | Terminated |
| Reason | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. |
| Root cause | 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 | 110 |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM Medical Components, Inc., Sep 21, 2012 |