# FDA recall Z-2452-2018

> **Ethicon, Inc.** · Class II · device recall initiated 2018-05-07.

## Product

PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

## Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare  professional handling the subject product or a patient infection due to a breach of sterility within the packaging if  it goes unnoticed by the healthcare professional.

## Distribution

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

## Key facts

- **Recall number:** Z-2452-2018
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-07
- **Report date:** 2018-07-25
- **Termination date:** 2020-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2452-2018

## Citation

> AI Analytics. FDA recall Z-2452-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2452-2018. Source: US FDA. Licensed CC0.

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