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FDA Medical Device Recalls (openFDA)

Excelsior Medical Corp: 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

Recall number
Z-0044-2007
Recalling firm
Excelsior Medical Corp
Product
0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Status
Terminated
Initiated
2006-04-24
Posted
2006-10-19
Terminated
2006-10-26
Reason
The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
Root cause
Other
Action
Excelsior notified Hospira of the recall on 4/24/2006. Hospira notified Morris Dickson and Cardinal Health on 4/28/2006.
Quantity
466,000 units
Distribution
Worldwide.
Lot, serial or model codes
Product E0100-30, Lot 22-010-9D
510(k) numbers
not on file
PMA numbers
not on file
Product code
NGT
Firm FEI
1000122362
Firm city
Neptune
Firm state
NJ
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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