Z-1571-05

Ultrasound probe cover, sterile. Catalog No. 910811

Name: Z-1571-05 Ultrasound probe cover, sterile. Catalog No. 910811
Creator: North Coast Medi-Tek Inc
Published: 2005-06-07
License: https://open.fda.gov/license/

North Coast Medi-Tek / initiated 2005-06-07 / Terminated / root cause: packaging

FDA source

North Coast Medi-Tek Inc began a recall of Ultrasound probe cover, sterile. Catalog No. 910811 on 2005-06-07. The reason FDA records is "Customer observed unsealed packages". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1571-05
Status: Terminated
Initiated: 2005-06-07
Posted: 2005-09-21
Terminated: 2007-12-17
Recalling firm: North Coast Medi-Tek
Product: Ultrasound probe cover, sterile. Catalog No. 910811.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Customer observed unsealed packages.
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm called their customer and requested the customer to return un-sealed packages.
Quantity in commerce: 30 cases containing 10 units per case.
Distribution: The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
Product codes and lots: Lot number: 0520, expiration date: 1-10.

Product code KKX

K050322Class IIMicrotek Equipment DrapesMicrotek Medical, Inc. / cleared 2005-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)