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Terminated

Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT

FDA Recall Z-0082-06 · Posted 2005-10-21

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeLHI
Date Initiated2005-09-20
Date Terminated2006-01-20
Product Quantity1575 units

Reason for Recall

stress crack on the stopcock

Firm Action

The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. The products were sent to the recalling firm''s distributors in the Netherlands, Denmark, France, and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMMedrad, Inc. · 2005-06-17

Official Source

View FDA Recall →

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

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