FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
- Recall number
- Z-2040-2019
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
- Status
- Completed
- Initiated
- 2019-04-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Root cause
- Under Investigation by firm
- Action
- Cardinal Health issued notification letter by mail on 4/30/19 advising product defect, health risk and action to take: 1. INSPECT inventory for the affected 2. SEGREGATE and QUARANTINE all on-hand product; 3. RETURN acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST. Questions contact Cardinal Health at 800-292-9332
- Quantity
- not on file
- Distribution
- Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
- Lot, serial or model codes
- Lot Number: 907007
- 510(k) numbers
- ["K854547"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3014524790
- Firm city
- Mansfield
- 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
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