Recall Z-1071-2022
Microtek Medical Inc. · initiated April 8, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TMJ Arthroscopy Drape, 85''x 96''
Codes / lots: 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
Reason for recall
Latex content in product was labeled incorrectly as latex free.
FDA-determined cause: Under Investigation by firm
Action taken
All consignees were contacted on 04/08/2022 via email. Consignees should read the recall instruction, examine their inventory, and quarantine the lots listed in the letter. The consignees should also complete the enclosed response form and email it to recall@ecolab.com. If the consignee has further distributed the product, they should identify and notify their customers of the recall.
Details
- Recall number
- Z-1071-2022
- Initiated
- April 8, 2022
- Terminated
- June 5, 2024
- Product code
- PUI – Drape, Surgical, Exempt
- Quantity
- 12 cases (120 drapes)
- Distribution
- Distributed nationwide to CO, PA, and WI.
- Recalling firm
- Microtek Medical Inc., Saint Paul, MN