FDA DevicesClass II
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A ...
Published: June 24, 2026Recall ID: Z-2438-2026Category: devicesCountry: US
Reason for Recall / Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Product Description & Identification
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837
Affected Products
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98951 |
| Address 1 | 3 Lakes Dr |
| Code info | EBSI1705A UDI-DI 10653160382850 Lot 2025103090 EBSI1057A UDI-DI 10653160356875 Lot 2025120890 EBSI1498 UDI-DI 10193489111538 Lot 2025110690 EBSI1585 UDI-DI 10653160354796 Lot 2025102190 EBSI1621 UDI-DI 10653160358336 Lot 2025110390 EBSI1837 UDI-DI 10653160388555 Lot 2025102990 |
| Postal code | 60093-2753 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 49,654 kits total |
| Reason for recall | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260612 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution. OUS distribution pending.