Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 08714729244356, Lot/Batch Numbers: 26277188, 26599713, 26709826, 27170547, 27203658, 27339851, 27535146, 27728492, 27902047, 28320867, 28564218, 28616007, 28632345, 26138706, 26277189, 26411756, 26411757, 26599714, 26599715, 26709827, 26746119, 26746120, 26891840, 26891841, 26984254, 27254933, 27379026, 27379027, 27558597, 27645561, 27782880, 27980980, 27988374, 28320864, 28320865, 28320866, 28564219, 28564380, 28584613, 28616008, 28632340, 28632341, 28632342, 29513117
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Boston Scientific Corporation
- Reason for Recall:
- Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Product Codes/Lot Numbers:
GTIN 08714729244356, Lot/Batch Numbers: 26277188, 26599713, 26709826, 27170547, 27203658, 27339851, 27535146, 27728492, 27902047, 28320867, 28564218, 28616007, 28632345, 26138706, 26277189, 26411756, 26411757, 26599714, 26599715, 26709827, 26746119, 26746120, 26891840, 26891841, 26984254, 27254933, 27379026, 27379027, 27558597, 27645561, 27782880, 27980980, 27988374, 28320864, 28320865, 28320866, 28564219, 28564380, 28584613, 28616008, 28632340, 28632341, 28632342, 29513117
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0022-2024
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