# FDA recall Z-3137-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-07-23.

## Product

Medline Convenience Kit:  OPEN HEART A PACK, Product Number DYNJ43008N

## Reason for recall

The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-3137-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-23
- **Report date:** 2026-09-23

- **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-3137-2026

## Citation

> MORVS. FDA recall Z-3137-2026. Retrieved 2026-10-23 from https://api.morvs.ai/recall/Z-3137-2026. Source: US FDA. Licensed CC0.

---

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