Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
- Recall Initiated
- July 12, 2018
- Terminated
- July 2, 2020
- Recall Number
- Z-2935-2018
- 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
MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO MCBN350 MCBY390 MCCV240 MCDA860 MCDG370 MCDJ730 MCDP710 MCFA850 MCFB360 MCFD630 MCFM700 MCFS710 MCFX790 MKAD790 MKAG470 MKAT090 MKAX630 MCBA820 MCBYS20 MCCP980 MCFD640 MCFQ350 MKAR100 MCAC610 MCAT590 MCCH750 MCDQ920 MCFV690 MCAH750 MCFZ550
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).