FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B
- Recall number
- Z-3025-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B
- Status
- Open, Classified
- Initiated
- 2024-04-08
- Posted
- 2024-09-06
- Terminated
- not on file
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
- Quantity
- not on file
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- DYNJ0281516M , Lot Number 19EBW985 ; DYNJ0281516M , Lot Number 19FBS033 ; DYNJ0281516M , Lot Number 19GBE356 ; DYNJ0281516M , Lot Number 19GBN481 ; DYNJ0281516M , Lot Number 19SBC273 ; DYNJ0281516M , Lot Number 19VBH540 ; DYNJ0281516M , Lot Number 19LBS319 ; DYNJ0281516M , Lot Number 20ABZ597 ; DYNJ0281516M , Lot Number 20DBH983 ; DYNJ0281516M , Lot Number 20FBJ183 ; DYNJ0281516M , Lot Number 20HBK308 ; DYNJ0281516M , Lot Number 20JBZ789 ; DYNJ0281516M , Lot Number 20LBU288 ; DYNJ0281516M , Lot Number 21CBD769 ; DYNJ0281516M , Lot Number 21EMF053 ; DYNJ0281516M , Lot Number 21GMB207 ; DYNJ0281516M , Lot Number 21HMD725 ; DYNJ0281516M , Lot Number 21IMF128 ; DYNJ0281516M , Lot Number 21LMC143 ; DYNJ0281516M , Lot Number 22AMF940 ; DYNJ0281516M , Lot Number 22CMC800 ; DYNJ0281516M , Lot Number 22CMD981 ; DYNJ0281516M , Lot Number 22EMG839 ; DYNJ0281516M , Lot Number 22EMH435 ; DYNJ0281516M , Lot Number 22HMC805 ; DYNJ0281516M , Lot Number 22JMA630 ; DYNJ0281516M , Lot Number 22LMA629 ; DYNJ0281516M , Lot Number 23AMB717 ; DYNJ0281516M , Lot Number 23BMI443 ; DYNJ0281516M , Lot Number 23DMG317 ; DYNJ0281516M , Lot Number 23FMC971 ; DYNJ0281516M , Lot Number 23GMD118 ; DYNJ0281516M , Lot Number 23HMH453 ; DYNJ0281516M , Lot Number 23JMB170 ; DYNJ0281516M , Lot Number 23KME384 ; DYNJ0281516M , Lot Number 19AKA641 ; DYNJ0281516M , Lot Number 19BKD684 ; DYNJ0281516M , Lot Number 19DKC345 ; DYNJ0484979B , Lot Number 18LBO447 ; DYNJ0484979B , Lot Number 19CBU327
- 510(k) numbers
- ["K962826"]
- PMA numbers
- not on file
- Product code
- LRO
- 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