# FDA recall Z-2113-2020

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2020-03-27.

## Product

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity  1, UDI:  07613327376067

## Reason for recall

A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.

## Distribution

US:  AZ, CA, FL, GA,  ID, IL, IN, KS, MA, MO, PA, TN, TX,  VA, WA, WV  OUS:  None

## Key facts

- **Recall number:** Z-2113-2020
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-27
- **Report date:** 2021-02-03
- **Termination date:** 2022-10-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2113-2020

## Citation

> AI Analytics. FDA recall Z-2113-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2113-2020. Source: US FDA. Licensed CC0.

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