SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
FDA Recall Z-1572-05 · Posted 2005-09-21
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Recalling FirmNorth Coast Medi-Tek Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2005-01-18
Date Terminated2007-02-21
Product Quantity5 cases, each case containing 10 kits (50 total kits).
Reason for Recall
Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
Firm Action
The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.
Root Cause
Other
Distribution Pattern
The product was distributed to one customer: Source One Healthcare Technologies distribution center, 4434 Mulhauser Road #300, Hamilton, OH 45011.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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