Z-0082-06

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

Name: Z-0082-06 Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT
Creator: Medrad Inc
Published: 2005-09-20
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2005-09-20 / Terminated

FDA source

Medrad Inc began a recall of Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT on 2005-09-20. The reason FDA records is "stress crack on the stopcock". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0082-06
Status: Terminated
Initiated: 2005-09-20
Posted: 2005-10-21
Terminated: 2006-01-20
Recalling firm: Medrad, Inc.
Product: Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: stress crack on the stopcock
FDA root cause: Other
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.
Quantity in commerce: 1575 units
Distribution: 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.
Product codes and lots: Lot number 50577, 50578, 51219, 51220, 51221, and 52208

Product code LHI

K050456Class IIMedrad Avanta Fluid Management Injection SystemMedrad, Inc. / cleared 2005-06-17

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)