Z-1530-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,998 units
Product 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
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Code Information
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