Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T
FDA device recall Z-0103-06 · posted 2005-10-28 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- 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
- Action taken
- On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 10 units
- Distribution
- The products were shipped to distributors in OH and MO.
- Date initiated
- 2005-09-15
- Date posted
- 2005-10-28
- Date terminated
- 2005-11-22
- 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 Z-CATH (K003682) | Medical Components, Inc. | 2001-01-26 |