# FDA recall Z-0334-2018

> **DeRoyal Industries Inc** · Class II · device recall initiated 2017-12-19.

## Product

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows:  (a) Shoulder Arthroscopy Pack 89-8686.01  (b) Shoulder Arthroscopy Pack 89-8686.02  (c) Knee Arthro Pack 89-8687.01  (d) Knee Arthro Pack 89-8687.02    Product Usage: general surgical

## Reason for recall

DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.

## Distribution

Distributed to states of: CA and MO.

## Key facts

- **Recall number:** Z-0334-2018
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-19
- **Report date:** 2018-01-24
- **Termination date:** 2018-06-21

- **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-0334-2018

## Citation

> AI Analytics. FDA recall Z-0334-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0334-2018. Source: US FDA. Licensed CC0.

---

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