Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit...
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) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.
Affected Products
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.
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 CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733; Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147; Medline Kit SKU CDS984857N: UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804; Medline Kit SKU DYNJ51440B: UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445; Medline Kit SKU DYNJ58742J: UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534; Medline Kit SKU DYNJ63781B: UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309; Medlin... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 40 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.