FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
- Recall number
- Z-0898-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
- Status
- Terminated
- Initiated
- 2022-03-04
- Posted
- not on file
- Terminated
- 2023-03-20
- Reason
- Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
- Root cause
- Material/Component Contamination
- Action
- The recalling firm issued letters dated 3/4/2022 via regular mail informing the customer there was a sterility failure of the exterior of the syringe and in the event a syringe from the affected lot was placed on a sterile field, the sterile field may become compromised. The required actions were to immediately check their stock for the affected lot number, quarantine it, and then destroy it. The enclosed destruction form was to be completed listing the quantity of affected product destroyed, and once the form was returned, they would receive credit. If the product has been transferred to another individual or location, they were to notify them of the recall.
- Quantity
- 7,800 pouched syringes
- Distribution
- US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Lot #3139133, Exp. 11/01/2022.
- 510(k) numbers
- ["K082837"]
- PMA numbers
- not on file
- Product code
- NGT
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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