Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
- Recall Initiated
- July 12, 2018
- Terminated
- July 2, 2020
- Recall Number
- Z-2932-2018
- Firm Location
- Harleysville, PA
Reason for Recall
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.
Distribution
Nationwide distribution; worldwide distribution.
Lot / Code Info
MCAW430, MCBR560, MCCX620 MCCF020 MCFK440 MKAY620
Root Cause
Process control
Action Taken
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 product was further distributed, customers were asked to notify their sub-accounts. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The phone number to call is 215-256-4201. Customers are asked to complete and return a customer response form included with the recall letter by fax (215-256-9191) or email (complaints@medcompnet.com).