Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion k
FDA device recall Z-0161-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- mislabeled as right are actually left
- Action taken
- Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 100 trays
- Distribution
- Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.
- Date initiated
- 2009-09-02
- Date posted
- 2009-11-10
- Date terminated
- 2010-04-16
- 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 |
|---|---|---|
| MEDCOMP BIO-FLEX CS CATHETER (CS100) (K971925) | Medical Components, Inc. | 1998-02-23 |