FDA-Device2023-08-09Class II
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case,
Microtek Medical Inc.
Hazard
Certain lots of the products have a Naphthalene odor.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
9,293 cases/68,070 units for all products
Manufactured in
1 Ecolab Pl, N/A, Saint Paul, MN, United States
Products
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case, sterile; and (5) Ecolab Genesys Microtek C-Arm / Mobile X-Ray Drape, 104 cm x 188 cm (41 in x 74 in), Model 4951N, pkgd. 50/case, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2023Don't want to check this manually?
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