Recall Z-2239-2021— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2021-06-30, terminated 2023-02-24. It names one FDA 510(k) clearance: K143255. Product: Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.. Reason: There is a potential that 7F sheaths are packaged as 10F sheaths..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-30
- Terminated
- 2023-02-24
- Firm location
- South Jordan, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.