# K002507: Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 21, 2001 after 218 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 64 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011761: Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port (2001), 1 descendant of its own
- K032962: AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface (2003), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2385-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Oct 27, 2022 · Class I · Z-0351-2023: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pre
- Oct 27, 2022 · Class I · Z-0352-2023: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pre
- Dec 22, 2017 · Class II · Z-1323-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- May 9, 2017 · Class II · Z-2335-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Mar 20, 2017 · Class II · Z-2308-2017: The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted int
- Mar 20, 2017 · Class II · Z-2272-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2281-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2291-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2290-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2277-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2261-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2283-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2269-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2301-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2271-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2257-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2275-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2270-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2304-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2273-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2274-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2279-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2282-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2298-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2276-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2258-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2262-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2302-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2253-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2293-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2256-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2254-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2287-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2286-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2268-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2278-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2306-2017: The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted int
- Mar 20, 2017 · Class II · Z-2295-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2265-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2259-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2300-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2296-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2289-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2288-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2299-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2297-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2292-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2280-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Mar 20, 2017 · Class II · Z-2294-2017: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Source page: https://510kreport.com/device/K002507
Methodology: https://510kreport.com/methodology