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Equipment and table drapes recallZ-2250-2023 · Microtek Medical Inc. · initiated Jun 23, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Microtek Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Certain lots of the products have a Naphthalene odor.

FDA root cause category: Under Investigation by firm

What the company is doing

The recalling firm issued letters dated 6/15/2023 via email on 6/23/2023, unless they did not have an email address for the consignee, then those consignees were mailed a letter. The letter explained the reason for recall and requested the consignee immediately examine their inventory and quarantine the lots listed in the letter. The consignee is requested to dispose of product and packaging in accordance with hospital, administrative and/or local government policy and if unable to do so, they are instructed to call or email customer service to arrange for shipment of the affected product back to Ecolab. A response form was enclosed for return via email to report whether the consignee has affected product in their possession or not. The consignee is to indicate on the response form that they have read and understand the recall instructions, checked their stock and do not have any product to return, have checked their stock and are disposing of the listed inventory, or they have checked their stock and will send the listed inventory back to Ecolab. If the product was further distributed, the consignee is to identify and notify their customer at once of the product recall. A Distributor Response Form was also enclosed for completion. The Distributor Response Form is to report they have notified all customers that received the affected product and have provided their customers with a copy of the recall letter. The distributor is to report their customers' names, addresses, quantity of product shipped to the customer by SKU number and lot number, the amount the customer has available for disposal, and the date of disposal. The recall is being conducted to the user level.

Recall details

Recall number
Z-2250-2023
Status
Open, Classified
Initiated by the company
Jun 23, 2023
Posted by the FDA
Jul 28, 2023
Recalling firm
Microtek Medical Inc.
Quantity
9,293 cases/68,070 units for all products
Product code
PUI
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

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.

Code information (models, lots, serial numbers)

(1) Model 63620RT - Lot number 220301F, exp 3/3/2027; UDI-DI 00748426129386; (2) Model 60040S - Lot number 220305F, exp 3/5/2027; UDI-DI 00748426129348; (3) Model 60050S - Lot number 220305F, exp 3/5/2027; UDI-DI 00748426129355; (4) Model 890017 - Lot numbers 220110F, exp. 1/10/2027; 220108F, exp 1/8/2027; 220102F, exp 1/2/2027; and 211231F, exp 12/31/2026; UDI-DI 00748426063673; and (5) Model 4951N - Lot numbers 220110F, exp 1/10/2027; and 220109F, exp 1/9/2027; UDI-DI 00748426126767.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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