Recall Z-2940-2020 ยท MSD Catheter, Hemodialysis, Implanted
Medical Components, Inc dba MedComp
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
| Date | Jul 27, 2020 |
| Status | Terminated |
| Reason | Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer |
| Root cause | Under Investigation by firm |
| Action | Medcomp issued Urgent Medical Device Recall letter issued first class mail to the customers on July 27, 2020. Letter states reason for recall, health risk and action to take: " Immediately examine your inventory and quarantine all product subject to recall. " Options for disposition of affected product: o Return the product to Medcomp - Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization {RGA) number. The phone number to call is 215-256-4201. o Have individually packaged and sterilized 16F peelable introducers (MR191603) sent to use with th |
| Quantity | 132 eaches |
| Distribution | AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 Medical Components, Inc., Oct 3, 2001 |