# FDA recall Z-1591-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-03-03.

## Product

Medline Convenience kits used for various procedures:  1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A;   3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B;   5) CATH PACK, Model Number: DYNJ51338C;   6) BRISTOL MYELOGRAM, Model Number: DYNDH1228;   7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A;   8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   9) CATH LAB PACK, Model Number: DYNJ85070;   10) CT SCAN PACK, Model Number: DYNJ39515A;   11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ;   12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D;   13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974;   14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A;   15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020;   16) PORTACATH PACK, Model Number: DYNJ51240A;   17) RADIOLOGY PACK, Model Number: DYNJ43969;   18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I;   19)

## Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

## Key facts

- **Recall number:** Z-1591-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-04-23

- **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-1591-2025

## Citation

> AI Analytics. FDA recall Z-1591-2025. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1591-2025. Source: US FDA. Licensed CC0.

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