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FDA Medical Device Recalls (openFDA)

Nova Biomedical Corporation: ABG Replacement Pump Assembly Catalog Number: 37092

Recall number
Z-0830-04
Recalling firm
Nova Biomedical Corporation
Product
ABG Replacement Pump Assembly Catalog Number: 37092
Status
Terminated
Initiated
2004-03-30
Posted
2004-07-20
Terminated
2004-06-17
Reason
Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Root cause
Other
Action
Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.
Quantity
5 units
Distribution
CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany
Lot, serial or model codes
Devices shipped between March 30-31, 2004
510(k) numbers
not on file
PMA numbers
not on file
Product code
CHL
Firm FEI
1219029
Firm city
Waltham
Firm state
MA
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

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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

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