St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147
- 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:
- Sterilmed Inc
- Reason for Recall:
- Inadequate seal due to lack of adhesive glue
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product Codes/Lot Numbers:
Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0213-2018
Related Recalls
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.