Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S
FDA device recall Z-2218-2024 · posted 2024-06-27 · Open, Classified
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
- Action taken
- On 05/22/2024 and on 05/28/2024, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing them that the Instructions for Use (IFU) instructs users to "ensure that valve and the sheath are tightly connected before use" which may cause over-tightening of the luer fitting that may result in the swivel nut detaching from the Hemostasis valve adapter. Customers are instructed to: 1. Read and understand this letter and the IFU provided. There is no need to return product to Merit. 2. Post this notice and updated IFU on or near the affected products so users are aware of the recall. 3. Ensure that applicable personnel within your organization are made aware of this communication. 4. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice and updated IFU is immediately shared with them. Additional distribution details may be required by health authorities. 5. If you require paper IFUs, please contact RESPONSE@merit.com. 6. Please fill out, scan and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within 7 calendar days. If any questions - contact the Merit Sales Representative or Merit Customer Service via email at RESPONSE@merit.com or via phone at 801-208-4381 Hours: 6 am to 6 pm MST/Mon -Fri.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 52,410 (updated 06/14/2024)
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM,
- Date initiated
- 2024-05-22
- Date posted
- 2024-06-27
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Prelude Guide Sheath (K211405) | Merit Medical Systems, Inc. | 2021-10-04 |