Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 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.
Reported: August 18, 2021 Initiated: June 30, 2021 #Z-2238-2021
Product Description
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 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.
Reason for Recall
There is a potential that 7F sheaths are packaged as 10F sheaths.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 760 units
- Distribution
- US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 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.. Recalled by Merit Medical Systems, Inc.. Units affected: 760 units.
Why was this product recalled? ▼
There is a potential that 7F sheaths are packaged as 10F sheaths.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2238-2021.
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