FDA Medical Device Recalls (openFDA)
Excelsior Medical Corp: Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical, Neptune, NJ. This product is used for the flushing of venous access devices and intravenous tubing.
- Recall number
- Z-0973-2009
- Recalling firm
- Excelsior Medical Corp
- Product
- Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical, Neptune, NJ. This product is used for the flushing of venous access devices and intravenous tubing.
- Status
- Terminated
- Initiated
- 2009-01-13
- Posted
- 2009-02-06
- Terminated
- 2009-08-06
- Reason
- Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.
- Root cause
- Packaging process control
- Action
- An Urgent Medical Device Recall letter (dated January 13, 2009) was sent to consignees via certified mail, with return receipt requested. The letter provided the reason for the recall and instructions to discontinue use and return (or destroy) the recalled product. The letter also instructed customers to complete the enclosed Customer Reply Form and fax (866-360-6211) to Excelsior Medical Corporation. If the affected product is destroyed on site, fax a copy of the certificate of destruction with the completed Customer Reply Form. Arrangements will be made by Excelsior Medical Corporation for the return of recalled product. Please direct questions to Excelsior Medical Customer Service at 800-487-4276.
- Quantity
- 341,580 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Product codes: E0100 20, 100 92-240 and 100 92-30: External Lot #/Expiration Date 01-003-DS 9/1/2008, 34-021-BB 10/1/2008, 46-060-9D 10/1/2008, 34-023-BB 10/1/2008, 08-024-DS 5/1/2009, 09-005-DS 7/1/2009, 58-012-9D 10/1/2009, 58-025-9D 10/1/2009, 58-042-9D 10/1/2009, 59-007-9D 11/1/2009, 11-013-DS 7/1/2009, 12-011-DS 7/1/2009, 60-015-9D 12/1/2009, 60-020-9D 12/1/2009, 62-024-9D 2/1/2010, 62-025-9D 2/1/2010, 63-032-9D 3/1/2010, 64-027-9D 4/1/2010, 65-008-9D 5/1/2010, 19-002-DS 4/1/2010, 19-015-DS 5/1/2010, 66-029-9D 6/1/2010, 20-008-DS 5/1/2010, 67-036-9D 7/1/2010, 69-021-9D 9/1/2010, 69-036-9D 9/1/2010, 70-018-9D 10/1/2010, 23-014-DS 8/1/2010 and 24-019-DS 8/1/2010.
- 510(k) numbers
- ["K053120"]
- 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