FDA DevicesClass II
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit...
Published: February 4, 2026Recall ID: Z-1199-2026Category: devicesCountry: US
Reason for Recall / Hazard
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Product Description & Identification
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Affected Products
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98226 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | Medline Kit SKU DYNJ35494C: UDI/DI 10198459117879 (EA) 40198459117870 (CS), Lot Number 25KMD420; Medline Kit SKU DYNJ38582O: UDI/DI 10198459603709 (EA) 40198459603700 (CS), Lot Number 25KMI679; Medline Kit SKU DYNJ82084F: UDI/DI 10198459089206 (EA) 40198459089207 (CS), Lot Number 25KMD145. |
| Postal code | 60093-2753 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 96 units |
| Reason for recall | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251212 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260128 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.