ClearanceBrief
Recall Z-1071-2022 ยท PUI Drape, Surgical, Exempt

Microtek Medical Inc.

TMJ Arthroscopy Drape, 85''x 96''

DateApr 8, 2022
StatusTerminated
ReasonLatex content in product was labeled incorrectly as latex free.
Root causeUnder Investigation by firm
ActionAll 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.
Quantity12 cases (120 drapes)
DistributionDistributed nationwide to CO, PA, and WI.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.