# FDA recall Z-0016-2019

> **COVIDIEN LLC** · Class II · device recall initiated 2018-08-01.

## Product

Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716    Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

## Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0016-2019
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2018-10-10
- **Termination date:** 2020-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0016-2019

## Citation

> AI Analytics. FDA recall Z-0016-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0016-2019. Source: US FDA. Licensed CC0.

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