Skip to the content

FDA Medical Device Recalls (openFDA)

Medrad Inc: Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT

Recall number
Z-0083-06
Recalling firm
Medrad Inc
Product
Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
Status
Terminated
Initiated
2005-09-20
Posted
2005-10-21
Terminated
2006-01-20
Reason
stress crack on the stopcock
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
850 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.
Lot, serial or model codes
Lot numbers 50627, 50628, 51069, 51070, 51071, and 51747
510(k) numbers
["K050456"]
PMA numbers
not on file
Product code
LHI
Firm FEI
2520313
Firm city
Indianola
Firm state
PA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Search this register