Recall record at a glance
| Official record | Z-2251-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Microtek Medical Inc. |
| Report date | Aug 9, 2023 |
| Recall initiation date | Jun 23, 2023 |
| Quantity | 9,293 cases/68,070 units for all products |
| Location | Saint Paul, MN, United States |
Official 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.
Why the product was recalled
Certain lots of the products have a Naphthalene odor.
Distribution information
Worldwide distribution - US Nationwide and the country of Canada.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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