# FDA recall Z-0085-2018

> **Bioseal Corporation** · Class II · device recall initiated 2017-10-18.

## Product

Custom surgical kits labeled as follows:  (a) Suture Removal Set, 910-0002  (b) Instrument Set, INST03/20  (c) Suture Removal Set, SUT309/100  (d) Incision & Drainage Tray, INC03/20  (e) Suture Removal Set, SUT103/50  (f) General Purpose Tray, GPT010/25  (g) General Purpose Tray, GPT002/50

## Reason for recall

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

## Distribution

CA, IL, NC, VT

## Key facts

- **Recall number:** Z-0085-2018
- **Recalling firm:** Bioseal Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-10-18
- **Report date:** 2017-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Placentia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2018

## Citation

> AI Analytics. FDA recall Z-0085-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0085-2018. Source: US FDA. Licensed CC0.

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