Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20

Class I - Dangerous

🏥 Medical Devices Recalled: March 1, 2024 Cook Incorporated Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
1)JCD10.0-38-20 (01)00827002009936(17) Lot Numbers: 15794371, 15794373, 15794374, 15806068, 15816198, 15816199 15816200 2) JCD20.0-38-20 (01)00827002014718(17) Lot Numbers: 15784153, 15784159, 15784160, 15794192, 15794199, 15794202. 15804028 3) JCD22.0-38-20 (01)00827002014725(17) Lot Numbers: 15794207, 15806062 4) JCD6.0-38-15 (01)00827002009448(17) Lot Number: 15814407 5) JCD8.0-38-15 (01)00827002009998(17) Lot Numbers: 15797971, 15797979 6) JCD8.0-38-20 (01)00827002009806(17) Lot Number:15791073
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:: Cook Incorporated
Reason for Recall:: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20

Product Codes/Lot Numbers:

1)JCD10.0-38-20 (01)00827002009936(17) Lot Numbers: 15794371, 15794373, 15794374, 15806068, 15816198, 15816199 15816200 2) JCD20.0-38-20 (01)00827002014718(17) Lot Numbers: 15784153, 15784159, 15784160, 15794192, 15794199, 15794202. 15804028 3) JCD22.0-38-20 (01)00827002014725(17) Lot Numbers: 15794207, 15806062 4) JCD6.0-38-15 (01)00827002009448(17) Lot Number: 15814407 5) JCD8.0-38-15 (01)00827002009998(17) Lot Numbers: 15797971, 15797979 6) JCD8.0-38-20 (01)00827002009806(17) Lot Number:15791073