FDAFDA · Food and drugs·Recall number Z-1470-2022
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168 Product Description: convenience kits labeled as follows:
Published August 3, 2022 · Recall initiated: June 6, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Kits contain leaking bottles of isopropyl alcohol
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - SPT
- Distributor
- US Nationwide distribution.
- Lot
- a. Model Number CDS984642, Lot codes: 19JBB553 b. Model Number DYNJ902880J, Lot codes: 21FBR331, 21HBD394, 21IBP835, 21KBM214, 21DBE158 c. Model Number DYNJ902880K, Lot codes: 22BBD964, 21KBV788, 21LBN478 e. Model Number DYNJ904831F, Lot codes: 22DBT300, 22DBU172, 22BBO313, 21JBX260, 21KBO308 f. Model Number DYNJ905394A, Lot codes: 21HBJ840, 21IBU071, 21JBY922, 21DBS569, 21FBA011 g. Model Number DYNJ905394B, Lot codes: 22ABM646 h. Model Number DYNJ908168, Lot codes: 22EBB265
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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