Reported Aug 18, 2021 · Terminated
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Prelude SNAP Splittable Sheath Introducer
- REF
PLSX -1010size 10F
- Standard Length13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system
- Lot codes and dates
- Lot #I2067768
- Amount recalled
- 760 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There is a potential that 7F sheaths are packaged as 10F sheaths.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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