FDA Medical Device Recalls (openFDA)
North Coast Medi-Tek Inc: Ultrasound probe cover, sterile. Catalog No. 910811.
- Recall number
- Z-1571-05
- Recalling firm
- North Coast Medi-Tek Inc
- Product
- Ultrasound probe cover, sterile. Catalog No. 910811.
- Status
- Terminated
- Initiated
- 2005-06-07
- Posted
- 2005-09-21
- Terminated
- 2007-12-17
- Reason
- Customer observed unsealed packages.
- Root cause
- Other
- Action
- The recalling firm called their customer and requested the customer to return un-sealed packages.
- Quantity
- 30 cases containing 10 units per case.
- Distribution
- The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
- Lot, serial or model codes
- Lot number: 0520, expiration date: 1-10.
- 510(k) numbers
- ["K050322"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 1526414
- Firm city
- Mentor
- Firm state
- OH
- 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