FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
- Recall number
- Z-0104-06
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
- Status
- Terminated
- Initiated
- 2005-09-15
- Posted
- 2005-10-28
- Terminated
- 2005-11-22
- 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.
- Lot, serial or model codes
- Lot number MABY950
- 510(k) numbers
- ["K003682"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 2518902
- Firm city
- Harleysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28