🔍 RecallPedia

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Class I - Dangerous
🏥 Medical Devices Recalled: June 11, 2024 Merit Medical Systems Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number/UDI-DI code/Lot Numbers: PLS-1006/A 00884450467954 I2868407 I2873488 I2884101 I2889284 I2889285 I2889286 I2889287 I2889289 I2889288 I2903937 I2903938 I2903939 I2914399 I2925168 I2925169 PLS-1007/A 00884450467985 I2790541 I2862963 I2868410 I2868412 I2873489 I2882475 PLS-1008/A 00884450467992 I2868415 I2884088 I2889299 I2889300 I2661407S1 I2661408S1 I2925190 PLS-1009.5/A 00884450468036 I2862967 I2873494 I2889301 I2925173 PLS-1009/A 00884450468012 I2790564 I2873496 I2884103 I2889303 I2889306 PLS-1010.5/A 00884450468050 I2862970 PLS-1010/A 00884450468043 I2873497 I2873498 I2873499 I2873500 I2889327 PLS-1011/A 00884450468067 I2889329 PLS-2506/A 00884450468098 I2873501 I2889331 I2914419 PLS-2508/A 00884450468111 I2889334 PLS-2509/A 00884450468128 I2687649S1 I2868417 I2914426 PLS-2510/A 00884450468135 I2873503 I2889336 PLS-2511/A 00884450468159 I2889337 PLSX-1006/A 00884450489550 I2868420 I2873516 I2889355 I2914466 PLSX-1007/A 00884450489567 I2868421 I2873517 I2883775 I2903957 I2932677 PLSX-1008/A 00884450489574 I2889357 PLSX-1009/A 00884450489598 I2914468
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Merit Medical Systems, Inc.
Reason for Recall:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Product Codes/Lot Numbers:

Catalog Number/UDI-DI code/Lot Numbers: PLS-1006/A 00884450467954 I2868407 I2873488 I2884101 I2889284 I2889285 I2889286 I2889287 I2889289 I2889288 I2903937 I2903938 I2903939 I2914399 I2925168 I2925169 PLS-1007/A 00884450467985 I2790541 I2862963 I2868410 I2868412 I2873489 I2882475 PLS-1008/A 00884450467992 I2868415 I2884088 I2889299 I2889300 I2661407S1 I2661408S1 I2925190 PLS-1009.5/A 00884450468036 I2862967 I2873494 I2889301 I2925173 PLS-1009/A 00884450468012 I2790564 I2873496 I2884103 I2889303 I2889306 PLS-1010.5/A 00884450468050 I2862970 PLS-1010/A 00884450468043 I2873497 I2873498 I2873499 I2873500 I2889327 PLS-1011/A 00884450468067 I2889329 PLS-2506/A 00884450468098 I2873501 I2889331 I2914419 PLS-2508/A 00884450468111 I2889334 PLS-2509/A 00884450468128 I2687649S1 I2868417 I2914426 PLS-2510/A 00884450468135 I2873503 I2889336 PLS-2511/A 00884450468159 I2889337 PLSX-1006/A 00884450489550 I2868420 I2873516 I2889355 I2914466 PLSX-1007/A 00884450489567 I2868421 I2873517 I2883775 I2903957 I2932677 PLSX-1008/A 00884450489574 I2889357 PLSX-1009/A 00884450489598 I2914468

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2574-2024

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