FDA Medical Device Recalls (openFDA)
Deltec, Inc: Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24
- Recall number
- Z-0877-04
- Recalling firm
- Deltec, Inc
- Product
- Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with Dual-lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm I.D., 7 French Introducer Set, REF 21-8066-24
- Status
- Terminated
- Initiated
- 2004-03-29
- Posted
- 2004-07-20
- Terminated
- 2006-12-28
- Reason
- Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
- Root cause
- Other
- Action
- A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray.
- Quantity
- not on file
- Distribution
- The recalled products were shipped nationwide in the United States and worldwide.
- Lot, serial or model codes
- Lots M26975 and M27127
- 510(k) numbers
- ["K974471"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2183502
- Firm city
- Saint Paul
- Firm state
- MN
- 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