Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
Reason for Recall / Hazard
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Product Description & Identification
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
Affected Products
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98664 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 22BBJ540; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21LBM539; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21IBX286; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21HBM832; Medline Kit Number/SKU DYNJ47491F: UDI/DI each10193489586725, UDI/DI case 40193489586726, Lot Number: 21KMD114; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 22FMI371; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 21IMD775; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23JBD782; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 408899428... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 7004 kits |
| Reason for recall | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260430 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.