# FDA recall Z-0199-2018

> **DeRoyal Industries Inc** · Class II · device recall initiated 2017-10-16.

## Product

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads:  a) Incision and Drainage Tray, REF 47-763.04  b) Incision and Drainage Tray, REF 47-763.06  c) Incision and Drainage Tray, REF 47-763.07  d) Cricothyreotomy Ambulance Kit, REF 89-6752.01  e) Incision and Drainage Tray, REF 89-6818.02  f) Plastic Pack, REF 89-7212.04  g) Plastic Pack, REF 89-7212.05    Product Usage:  Custom surgical and procedural kits

## Reason for recall

Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.

## Distribution

US Nationwide distribution in the states of GA, IN, FL, and PA

## Key facts

- **Recall number:** Z-0199-2018
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-16
- **Report date:** 2017-12-13
- **Termination date:** 2020-08-21

- **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-0199-2018

## Citation

> AI Analytics. FDA recall Z-0199-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0199-2018. Source: US FDA. Licensed CC0.

---

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