Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Equipment and Table Drapes

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Equipment and Table Drapes see related information
Date Initiated by Firm June 23, 2023
Date Posted July 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2250-2023
Recall Event ID 92577
Product Classification Drape, surgical, exempt - Product Code PUI
Product 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 (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.
Recalling Firm/
Manufacturer		 Microtek Medical Inc.
1 Ecolab Pl
Saint Paul MN 55102-2739
Manufacturer Reason
for Recall		 Certain lots of the products have a Naphthalene odor.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 9,293 cases/68,070 units for all products
Distribution Worldwide distribution - US Nationwide and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-