# FDA recall Z-1529-2024

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

## Product

Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.   	  REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2  ORDER NUMBER (GPN): G35562

## 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-1529-2024
- **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-1529-2024

## Citation

> AI Analytics. FDA recall Z-1529-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1529-2024. Source: US FDA. Licensed CC0.

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