FDA Medical Device Recalls (openFDA)
Ecolab Inc: Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
- Recall number
- Z-0753-2017
- Recalling firm
- Ecolab Inc
- Product
- Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
- Status
- Terminated
- Initiated
- 2016-11-30
- Posted
- not on file
- Terminated
- 2019-08-21
- Reason
- The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.
- Root cause
- Incorrect or no expiration date
- Action
- Ecolab sent an "Urgent Medical Device Recall" letter dated November 30, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to quarantine the product for return. If the product was further distributed notify them of the recall. Requested customers to complete and return the Recall Response Form. For questions contact Customer Service by phone at 1-800-824-3027 or e-mail customerservice@microtekmed.com. For further questions please call (651) 250-4385.
- Quantity
- 40 cases (144 eaches per box)
- Distribution
- US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..
- Lot, serial or model codes
- 15302
- 510(k) numbers
- ["K882724"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 1000289767
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28