# FDA recall Z-1530-2024

> **Cook Incorporated** · Class II · device recall initiated 2024-03-01.

## Product

Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.  1)	JCD10.0-38-20  2)	JCD20.0-38-20  3)	JCD22.0-38-20  4)	JCD6.0-38-15  5)	JCD8.0-38-15  6)	JCD8.0-38-20

## Reason for recall

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

## Distribution

Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES,  GB, HK, IE, IL, IN, IT, NZ, SG.

## Key facts

- **Recall number:** Z-1530-2024
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-01
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1530-2024

## Citation

> AI Analytics. FDA recall Z-1530-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1530-2024. Source: US FDA. Licensed CC0.

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