Device product

TMJ Arthroscopy Drape, 85''x 96''

Z-1071-2022

April 08, 2022

Class II

Product summary

Firm: Microtek Medical Inc.
Event: Event 89956
Status: Terminated
Classification: Class II
Quantity: 12 cases (120 drapes)
Official record key: device-enforcement:Z-1071-2022

Official wording

Reason: Latex content in product was labeled incorrectly as latex free.

Code information: SKU Number 3601; Lot code/Expiration Date: Lot D181232, exp. 05/01/2022; Lot D181982, exp. 07/01/2022; Lot D202232, exp.08/01/2024; Lot D210742, exp. 03/01/2025; Lot D211372, exp. 05/01/2025; Lot D212562, exp. 09/01/2025; Lot D213122, exp. 11/01/2025; and Lot D213402, exp. 12/01/2025. UDI: 50748426008556

Distribution pattern: Distributed nationwide to CO, PA, and WI.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Latex content in product was labeled incorrectly as latex free.