Recall Z-1470-2022— MEDLINE INDUSTRIES, LP - SPT
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - SPT, initiated 2022-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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:. Reason: Kits contain leaking bottles of isopropyl alcohol.
- Recalling firm
- MEDLINE INDUSTRIES, LP - SPT
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-06
- Firm location
- Waukegan, IL, United States
Product description
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:
Reason for recall
Kits contain leaking bottles of isopropyl alcohol
Data sourced from openFDA. This site is unofficial and independent of the FDA.