RecallDepth

TMJ Arthroscopy Drape, 85''x 96''

This recall has been terminated (originally issued April 8, 2022).

Company
Microtek Medical Inc.
Recall Initiated
April 8, 2022
Terminated
June 5, 2024
Recall Number
Z-1071-2022
Quantity
12 cases (120 drapes)
Firm Location
Saint Paul, MN
Official Source
View on FDA website ↗

Reason for Recall

Latex content in product was labeled incorrectly as latex free.

Distribution

Distributed nationwide to CO, PA, and WI.

Lot / Code Info

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

Root 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.

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