Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet &
Summary
The FDA issued a Class II for Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab by Microtek Medical Inc.. Reason: Certain lots of the products have a Naphthalene odor..
Details
Source
Device Recall
External ID
Z-2251-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: (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.
Quantity Affected: 9,293 cases/68,070 units for all products
Reason for Recall
Certain lots of the products have a Naphthalene odor.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-23
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microtek Medical Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microtek Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microtek Medical Inc. have FDA actions?
Microtek Medical Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2251-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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