# FDA recall Z-1097-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class I · device recall initiated 2023-11-15.

## Product

MEDLINE Kits, trays, and packs labeled as follows:    a)	ARTERIAL LINE PACK, REF DYNJ65208A;   b)	CANCER SERVICE PORT KIT, REF DT22710;   c)	CAP CHANGE KIT, REF DYNDC2002A;   d)	CAP CHANGE KIT, REF DYNDC2723A;   e)	CAP CHANGE KIT, REF DYNDC2723B;   f)	CENTRAL LINE INSERTION PACK, REF CVI4805;   g)	CENTRAL LINE TRAY, REF CVI4705;   h)	CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A;   i)	CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B;   j)	CVC INSERTION PACK, REF CVI4720;   k)	CVC INSERTION PACK, REF CVI4720A;   l)	CVC INSERTION PACK, REF CVI4720AH;   m)	DERM SURG CUSTOM PACK, REF DYNDA1584C;   n)	ER CENTRAL LINE KIT, REF P155508D;   o)	FISTULA GRAFT KIT, REF DT20345A;   p)	IMPLANTED PORT ACCESS, REF DYNDC2765B;   q)	IVAD KIT, REF DYNDC2004B;   r)	KIT LINE INSERTION, REF CVI4730H;   s)	KIT LINE INSERTION, REF CVI4730;   t)	LINE CHANGE KIT, REF DYNDC2927A;   u)	MAX BARRIER PACK, REF DYNJ50717;   v)	MEDIPORT W/CHG, REF DYNDC2219B;   w)	MEDIPORT W/CHG, REF DYNDC2219BH;   x)	NICU PICC INSERT

## Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

## Distribution

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

## Key facts

- **Recall number:** Z-1097-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-15
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1097-2024

## Citation

> AI Analytics. FDA recall Z-1097-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1097-2024. Source: US FDA. Licensed CC0.

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