510(k) K042061 ยท NGT Saline, Vascular Access Flush
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
| Applicant | Becton Dickinson, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | Aug 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE ---
Intended for short or long term peripheral access to the ce Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE ---
Indicated for short or long-term p Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE ---
Intended for short or long term peripheral access to the cen Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE ---
Intended for short or long term peripheral access to the cent Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE ---
Indicated for Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE ---
Intended for short or long ter Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE ---
Intended for Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE ---
Indicated short or long-term peripheral acce Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE ---
Intended for short or long ter Terminated |
LJS | None listed |
| Oct 7, 2014 | Navilyst Medical, Inc PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE ---
Indicated for Terminated |
LJS | None listed |
| Sep 19, 2014 | Centurion Medical Products Corporation 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.