Recall Z-0104-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Medical Components, Inc dba MedComp
Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
| Date | Oct 28, 2005 (initiated Sep 15, 2005) |
| Status | Terminated |
| Reason | The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F |
| Root cause | Other |
| Action | On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product. |
| Quantity | 88 units |
| Distribution | The products were shipped to distributors in OH and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003682 | MEDCOMP Z-CATH Medical Components, Inc., Jan 26, 2001 |