Recall Z-1471-2022— 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: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A. 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: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A

Reason for recall

Kits contain leaking bottles of isopropyl alcohol

Data sourced from openFDA. This site is unofficial and independent of the FDA.