Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Reported: May 29, 2024 Initiated: March 14, 2024 #Z-1874-2024
Product Description
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Reason for Recall
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 18 units
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY. Recalled by Merit Medical Systems, Inc.. Units affected: 18 units.
Why was this product recalled? ▼
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1874-2024.
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