Recall record at a glance
| Official record | Z-0155-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Oct 30, 2024 |
| Recall initiation date | Sep 4, 2024 |
| Quantity | 1460 units |
| Location | Northfield, IL, United States |
Official product description
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR ARM PACK, REF DYNJ50712D; h) IR PACK, REF DYNJ67324; i) PL. CATHETERISME CARDIAQUE, REF HCT093J
Why the product was recalled
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
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.