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Terminated

Ultrasound probe cover, sterile. Catalog No. 910811.

FDA Recall Z-1571-05 · Posted 2005-09-21

Recalling FirmNorth Coast Medi-Tek Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2005-06-07
Date Terminated2007-12-17
Product Quantity30 cases containing 10 units per case.

Reason for Recall

Customer observed unsealed packages.

Firm Action

The recalling firm called their customer and requested the customer to return un-sealed packages.

Root Cause

Other

Distribution Pattern

The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050322MICROTEK EQUIPMENT DRAPESMicrotek Medical, Inc. · 2005-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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