Recall Z-2935-2018 ยท MPB Catheter, Hemodialysis, Non-Implanted
Medical Components, Inc dba MedComp
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
| Date | Jul 12, 2018 |
| Status | Terminated |
| Reason | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. |
| Root cause | Process control |
| Action | On July 12, 2018, the firm sent a Product Recall letter to its customers. Customers were provided with a full list of product codes and lot numbers and informed that those items had been recalled due to a potential for the suture wings to crack or break. Customers were informed that implanted catheters with intact suture wings do not need to be removed. However, an alternative method of catheter securement should be initiated for all implanted catheters, due to the potential for the suture wings to crack or break. Customers were instructed to return all unused recalled product to Medcomp. If |
| Distribution | Nationwide distribution; worldwide distribution. |
| FDA record | Open on fda.gov |