Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots, REF/UDI-DI/Lot(Expiration): PL17-160-000/00818075010455/ 900164(8/31/2022), 900165(8/31/2022), 900172(8/31/2022), 900177(9/30/2022), 900180(9/30/2022), 900186(10/31/2022), 900187(10/31/2022), 900188(10/31/2022), 900193(10/31/2022), 900196(12/31/2022), 900199(12/31/2022), 900202(12/31/2022), 900221(2/28/2023), 900222(2/28/2023), 900225(2/28/2023), 900226(3/31/2023), 20441(11/30/2023), 20476(11/30/2023), 20650(12/31/2023); PL17-160-045/00818075010462/900167(8/31/2022), 900168(8/31/2022), 900169(8/31/2022), 900174(8/31/2022), 900175(8/31/2022), 900179(9/30/2022), 900181(9/30/2022), 900183(10/31/2022), 900185(10/31/2022), 900205(1/31/2023), 900206(1/31/2023), 900210(1/31/2023), 900211(1/31/2023), 900215(1/31/2023), 900220(1/31/2023), 900219(1/31/2023), 900217(2/28/2023), 900223(2/28/2023), 900224(2/28/2023); PL17-160-090/00818075010479/900170(8/31/2022), 900171(8/31/2022), 900178(9/30/2022), 900182(9/30/2022), 900184(10/31/2022), 900192(11/30/2022), 900195(11/30/2022), 900209(1/31/2023), 900228(3/31/2023)
- 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:
- Scientia Vascular, Inc.
- Reason for Recall:
- Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Product Codes/Lot Numbers:
All lots, REF/UDI-DI/Lot(Expiration): PL17-160-000/00818075010455/ 900164(8/31/2022), 900165(8/31/2022), 900172(8/31/2022), 900177(9/30/2022), 900180(9/30/2022), 900186(10/31/2022), 900187(10/31/2022), 900188(10/31/2022), 900193(10/31/2022), 900196(12/31/2022), 900199(12/31/2022), 900202(12/31/2022), 900221(2/28/2023), 900222(2/28/2023), 900225(2/28/2023), 900226(3/31/2023), 20441(11/30/2023), 20476(11/30/2023), 20650(12/31/2023); PL17-160-045/00818075010462/900167(8/31/2022), 900168(8/31/2022), 900169(8/31/2022), 900174(8/31/2022), 900175(8/31/2022), 900179(9/30/2022), 900181(9/30/2022), 900183(10/31/2022), 900185(10/31/2022), 900205(1/31/2023), 900206(1/31/2023), 900210(1/31/2023), 900211(1/31/2023), 900215(1/31/2023), 900220(1/31/2023), 900219(1/31/2023), 900217(2/28/2023), 900223(2/28/2023), 900224(2/28/2023); PL17-160-090/00818075010479/900170(8/31/2022), 900171(8/31/2022), 900178(9/30/2022), 900182(9/30/2022), 900184(10/31/2022), 900192(11/30/2022), 900195(11/30/2022), 900209(1/31/2023), 900228(3/31/2023)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1249-2023
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