THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
FDA device recall Z-2693-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- 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.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 90
- Distribution
- Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands
- Date initiated
- 2011-05-19
- Date posted
- 2011-06-28
- Date terminated
- 2016-10-24
- Location
- Harleysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 (K030502) | Medcomp | 2003-05-20 |