# FDA recall Z-0637-2018

> **DeRoyal Industries Inc** · Class II · device recall initiated 2018-01-22.

## Product

Custom sterile surgical packs labeled as follows:  GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO    Use: Shoulder Arthroscopy

## Reason for recall

DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

## Distribution

US Distribution to: NY

## Key facts

- **Recall number:** Z-0637-2018
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-22
- **Report date:** 2018-02-28
- **Termination date:** 2020-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2018

## Citation

> AI Analytics. FDA recall Z-0637-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0637-2018. Source: US FDA. Licensed CC0.

---

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