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 Drapes, Table Drapes, Surgical Room Turnover Kits

  • 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 Drapes, Table Drapes, Surgical Room Turnover Kits see related information
Date Initiated by Firm June 23, 2023
Date Posted July 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2251-2023
Recall Event ID 92577
Product Classification Bedding, disposable, medical - Product Code KME
Product Equipment and table drapes and Surgical Room Turnover (SRT) Kits:

(1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile;
(2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile;

Surgical Room Turnover (SRT) Kits:

(3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile;
(4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-sterile;
(5) Ecolab CleanOp Infection Control System, Model BPGN-02, 10/case, non-sterile;
(6) Ecolab Genesys CleanOp Infection Control System, Model HFH-02, 12/case, non-sterile;
(7) Ecolab Genesys CleanOp Infection Control System, Model HKHA-02, 15/case, non-sterile;
(8) Ecolab CleanOp Infection Control System, Model JFKSC-01, 15/case, non-sterile;
(9) Ecolab Genesys CleanOp Infection Control System, Model LH-LD-05, 12/case, non-sterile;
(10) Ecolab CleanOp Infection Control System, Model NEGM-CV-01D, 9/case, non-sterile;
(11) Ecolab Genesys CleanOp Infection Control System, Model PMMC-02D, 12/case, non-sterile;
(12) Ecolab Genesys CleanOp Infection Control System, Model PMMC-SP-01D, 12/case, non-sterile;
(13) Ecolab Genesys CleanOp Infection Control System, Model SHMC-06, 15/case, non-sterile;
(14) Ecolab CleanOp Infection Control System, Model SR-01D, 12/case, non-sterile;
(15) Ecolab CleanOp Infection Control System, Model SVB-OSC-01, 12/case, non-sterile;
(16) Ecolab CleanOp Infection Control System, Model UCLA-LD-03, 12/case, non-sterile;
(17) Ecolab CleanOp Infection Control System, Model VAIC-03, 12/case, non-sterile; and
(18) Ecolab Genesys CleanOp Infection Control System, Model VAIC-CP-02, 15/case, non-sterile.
Code Information (1) Model ABTSLSAN - Lot numbers 220309D, exp 3/9/2027; and 220302D, exp 3/2/2027; UDI-DI 50748426077262; (2) Model ABTSLSN - Lot number 220301D, exp 3/1/2027; UDI-DI 50748426077255; (3) Model ALHS-02 - Lot numbers 1392JX0100, exp 9/1/2027; 2452JX3000, exp 11/1/2027; 3402JX2000, exp 10/1/2027; 4382JX0900, exp 9/1/2027; 4442JX1100, exp 11/1/2027; and 5422JX0100, 10/1/2027; UDI-DI 00748426133512; (4) Model ALHS-SS-01 - Lot number 6382JX1000, exp 9/1/2027; UDI-DI 00748426123131; (5) Model BPGN-02 - Lot numbers 2362JX2100, exp 9/1/2027; and 5412JX3200, exp 10/1/2027; UDI-DI 00748426080021; (6) Model HFH-02 - Lot number 2362JX1000, exp 9/1/2027; UDI-DI 00748426124688; (7) Model HKHA-02 - Lot numbers 1372JX0400, exp 9/1/2027; and 3412JX0700, exp 10/1/2027; UDI-DI 00748426077809; (8) Model JFKSC-01 - Lot numbers 6372JX1200, exp 9/1/2027; and 6372JX1300, exp 9/1/2027; UDI-DI 00748426078417; (9) Model LH-LD-05 - Lot numbers 7372JX2400, exp 9/1/2027; and 2422JX1900, exp 10/1/2027; UDI-DI 00748426082803; (10) Model NEGM-CV-01D - Lot numbers 5322JX1100, exp 8/12/2027; and 2013JX3400, exp 1/3/2028; UDI-DI 00748426132034; (11) Model PMMC-02D - Lot numbers 2332JX0900, exp 8/1/2027; 3362JX1200, exp 9/1/2027; and 2422JX2200, 10/1/2027; UDI-DI 00748426132034; (12) Model PMMC-SP-01D - Lot numbers 6282JX2600, exp 7/1/2027; 7372JX1900, exp 9/1/2027; 2412JX2300, exp 10/1/2027; and 6432JX0500, 10/1/2027; UDI-DI 00748426125753; (13) Model SHMC-06 - Lot numbers 2342JX0100, exp 8/1/2027; 1372JX0200, exp 9/1/2027; 3402JX1300, exp 10/1/2027; 6422JX0700, exp 10/1/2027; 6442JX0100, exp 11/1/2027; and 5312JX0100, exp 8/1/2027; UDI-DI 00748426068258; (14) Model SR-01D - Lot numbers 1362JX0300, exp 9/5/2027; and 5372JX0700, exp 9/16/2027; UDI-DI 00748426128723; (15) Model SVB-OSC-01 - Lot numbers 3392JX0100, exp 9/1/2027; and 2412JX3300, exp 10/1/2027; UDI-DI 00748426109326; (16) Model UCLA-LD-03 - Lot number 3382JX2100, exp 9/1/2027; UDI-DI 00748426115228; (17) Model VAIC-03 - Lot numbers 3282JX2500, exp 7/1/2027; 1442JX0600, 10/1/2027; 2432JX1700, exp 10/1/2027; and 4023JX3100, 1/1/2028; UDI-DI 00748426078837; and (18) Model VAIC-CP-02 - Lot number 5332JX2100, exp 8/1/2027; UDI-DI 00748426078813.
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.
-
-