Device product

Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131

Z-1475-2022

June 06, 2022

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - SPT
Event: Event 90516
Status: Ongoing
Classification: Class II
Quantity: 1880 units
Official record key: device-enforcement:Z-1475-2022

Official wording

Reason: Kits contain leaking bottles of isopropyl alcohol

Code information: Lot Code: a. Model number DYNDP1127A, Lot Numbers: 22ABG455, 21FBU537, 21IBF632, 21JBY751, 21LBB154, b. Model number DYNDP1131, Lot Numbers: 22DBT130, 22DBK391, 22ABC822, 22OBE201, 21IBR746, 21JBL238, 21KBU021,

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Kits contain leaking bottles of isopropyl alcohol