FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
- Recall number
- Z-0112-2024
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
- Status
- Open, Classified
- Initiated
- 2023-09-13
- Posted
- 2023-10-13
- Terminated
- not on file
- Reason
- Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
- Root cause
- Process change control
- Action
- Cardinal Health notified consignees on about 09/13/2023 via letter titled "URGENT MEDICAL DEVICE PRODUCT CORRECTION." Customers were instructed to review inventory for the affected product code and lot, ensure all personnel are informed cease utilizing the affected product with needleless IV connectors, post a copy of the notification in the storeroom where the product is stored, and notify any customers if the product has been further distributed/forwarded. Additionally, customers were asked to complete and return the included acknowledgment form.
- Quantity
- 3.927,994 units
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY
- Lot, serial or model codes
- Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- 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