FDA DevicesClass II
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; ...
Published: March 4, 2026Recall ID: Z-1433-2026Category: devicesCountry: US
Reason for Recall / Hazard
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Product Description & Identification
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
Affected Products
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98319 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | 1) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25JBG340; 2) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25EBV829; 3) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25CBM029; 4) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25BBI797; 5) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25ABW687; 6) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23EBN045; 7) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23DBM064; 8) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25HBB845; 9) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25GBS259; 10) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25DBR145; 11) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25BBS769; 12) DYKM2013A, UDI-DI: 101953274... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 10550 units (495 additional units 3/27/26) |
| Reason for recall | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260105 |
| Initial firm notification | Letter |
| Center classification date | 20260220 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.