Z-1071-2022 Class II Terminated
FDA device recall Z-1071-2022 was initiated by Microtek Medical Inc. on April 8, 2022 and is designated Class II. Reason for recall: Latex content in product was labeled incorrectly as latex free. The recall status is terminated (terminated June 5, 2024). Affected quantity: 12 cases (120 drapes).
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- April 8, 2022
- Termination Date
- June 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 cases (120 drapes)
Product Description
TMJ Arthroscopy Drape, 85''x 96''
Reason for Recall
Latex content in product was labeled incorrectly as latex free.
Distribution Pattern
Distributed nationwide to CO, PA, and WI.
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