# FDA recall Z-1338-2018

> **Ethicon, Inc.** · Class II · device recall initiated 2018-01-10.

## Product

PDS Plus Antibacterial (Polydioxanone) Suture  Size 0 PDS Plus Violet 36   Single Armed CT-1 Needle

## Reason for recall

Three (3) lots were distributed with the incorrect expiry date on the label. The lots  were labeled with an expiry date of five (5) years from date of manufacture instead  of the correct expiry date of two (2) years from date of manufacture.

## Distribution

Distribution US Nationwide, Canada, India, and Colombia.

## Key facts

- **Recall number:** Z-1338-2018
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-10
- **Report date:** 2018-04-18
- **Termination date:** 2019-04-11

- **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-1338-2018

## Citation

> AI Analytics. FDA recall Z-1338-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1338-2018. Source: US FDA. Licensed CC0.

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