THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
- Recall Initiated
- May 19, 2011
- Posted
- June 28, 2011
- Terminated
- October 24, 2016
- Recall Number
- Z-2693-2011
- Quantity
- 90
- Firm Location
- Harleysville, PA
Reason for Recall
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.
Distribution
Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands
Lot / Code Info
Lot # MAZX990; Catalog # THD155428, Exp Date 2013/03
Root Cause
Mixed-up of materials/components
Action Taken
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.