Device product

Medline CHEST TUBE REORDER NO: DYNJ36762A

Z-1683-2022

July 21, 2022

Class II

Product summary

Firm: Medline Industries Inc.
Event: Event 90689
Status: Ongoing
Classification: Class II
Quantity: 300 kits
Official record key: device-enforcement:Z-1683-2022

Official wording

Reason: Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit

Code information: Model Number: DYNJ36762A UDI-DI Code (GTIN Insert/GTIN Case / Lot Number: (01)1019348989440/(01)40193489894401 / 21ILA164 (01)1019348989440/(01)40193489894401 / 21ILA986 (01)1019348989440/(01)40193489894401 / 21JLA315 (01)1019348989440/(01)40193489894401 / 21KLA005 (01)1019348989440/(01)40193489894401 / 21KLA162 (01)1019348989440/(01)40193489894401 / 21KLA629

Distribution pattern: U.S. Nationwide distribution in the state of AL.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit