FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
- Recall number
- Z-2988-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
- 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
- DYNJRA0377B, Lot Number 19DDB791 ; DYNJRA0377B, Lot Number 21KDA359 ; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJG
- 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