Recall record at a glance
| Official record | Z-2765-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Sep 4, 2024 |
| Recall initiation date | Apr 8, 2024 |
| Location | Northfield, IL, United States |
Official product description
Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) ARTHROGRAM TRAY , Pack Number DYNDH1648; 7) ARTHROGRAM TRAY , Pack Number PAIN1396 ; 8) ARTHROGRAM/ASPIRATION RADIOLOG, Pack Number DYNJRA2152 ; 9) ARTHROGRAPH TRAY, Pack Number MNS12670B; 10) ARTHROSCOPY , Pack Number DYNJ909699 ; 11) GLMI ARTHROGRAM KIT: BIG TREE , Pack Number DYNDH1752; 12) HANA TABLE, Pack Number DYNJ908424A; 13) JC HIP ARTHROSCOPY, Pack Number DYNJ907481 ; 14) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480 ; 15) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480A; 16) JC SHOULDER ARTHROSCOPY , Pack Number DYNJ907479A; 17) LUMBAR DRAIN PACK , Pack Number DYNJ67379; 18) LUMBAR DRAIN PACK , Pack Number DYNJ67379H ; 19) OPEN SHOULDER CDS , Pack Number CDS983316D ; 20) ORTHO SPINE PACK, Pack Number DYNJ59720A ; 21) ORTHO SPINE PACK, Pack Number DYNJ59720B ; 22) PODIATRY TRAY-LF, Pack Number DYNJ51178D ; 23) TOTAL KNEE CDS-LF , Pack Number CDS940845L ; 24) TOTAL KNEE CDS-LF , Pack Number DYNJ907028 ; 25) TOTAL KNEE CDS-LF , Pack Number DYNJ907028A; 26) TOTAL KNEE CDS-LF , Pack Number DYNJ907028C
Why the product was recalled
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.
Distribution information
Worldwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.