# FDA recall Z-1096-2024

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

## Product

MEDLINE Kits, trays, and packs labeled as follows:    a)	DIALYSIS FISTULA KIT, REF DYNDC3106,   b)	ENDO KIT, REF DYKE1346D,   c)	ENDO KIT, REF DYKE1892A,   d)	ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,   e)	ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I,   f)	FREQUENT DAILY VAD, REF DYNDC3184,   g)	IMPLANTED VASCULAR ACCESS, REF DYNDC2842,   h)	INFANT COARTATION PACK, REF DYNJ54822D,   i)	INFANT OPEN HEART PUMP, REF DYNJ904068D,   j)	INFUSA PORT DRESSING KIT, REF DYNDC3192,   k)	LVAD DRIVELINE MANAGEMENT KIT, REF DM1165,   l)	LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B,   m)	OPEN HEART ACCESSORY CDS, REF CDS984289K,   n)	PACEMAKER PK SHSC-LF, REF DYNJ46785C,   o)	PERICARDIAL KIT, REF DYNDA2212B,   p)	PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B,   q)	PUH PERCUTANEOUS ECMO, REF DYNJ907554A,   r)	PUH PERCUTANEOUS ECMO, REF DYNJ907554C

## 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-1096-2024
- **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-1096-2024

## Citation

> AI Analytics. FDA recall Z-1096-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1096-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*