FDA Medical Device Recalls (openFDA)
Excelsior Medical Corp: Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
- Recall number
- Z-1989-2016
- Recalling firm
- Excelsior Medical Corp
- Product
- Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
- Status
- Terminated
- Initiated
- 2016-04-28
- Posted
- 2016-06-14
- Terminated
- 2017-08-08
- Reason
- Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
- Root cause
- Nonconforming Material/Component
- Action
- Excelsior Medical Inc. sent a recall letter on 4/29/2016 via certified mail. Customers are instructed to discontinue using the product subject to this recall. Customers are requested to complete the customer reply form and fax it (866) 807-3714, so arrangements can be made to return the product to Excelsior.
- Quantity
- 184,500
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Product Code, Lot number, Expiration date. 513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017
- 510(k) numbers
- ["K023740"]
- PMA numbers
- not on file
- Product code
- NZW
- 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
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