FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
- Recall number
- Z-1121-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
- Status
- Open, Classified
- Initiated
- 2022-12-07
- Posted
- 2023-02-10
- Terminated
- not on file
- Reason
- The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- Root cause
- Under Investigation by firm
- Action
- The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."
- Quantity
- 1537 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Reorder Number DYNDH1641A, GTIN 40195327005830, Lot # 22HMH339
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OIB
- 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