FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system.
- Recall number
- Z-1910-2008
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system.
- Status
- Terminated
- Initiated
- 2008-04-11
- Posted
- 2008-09-16
- Terminated
- 2008-10-28
- Reason
- kit contains incorrect component
- Root cause
- Mixed-up of materials/components
- Action
- The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
- Quantity
- 250 units
- Distribution
- The products were shipped to customers in PA and TX.
- Lot, serial or model codes
- Lot number MAPA880
- 510(k) numbers
- ["K053345"]
- 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