Recall Z-2693-2011 ยท MSD Catheter, Hemodialysis, Implanted
Medical Components, Inc dba MedComp
THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
| Date | Jun 28, 2011 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer. |
| Root cause | Mixed-up of materials/components |
| Action | Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225. |
| Quantity | 90 |
| Distribution | Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030502 | 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 Medcomp, May 20, 2003 |