See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS...
Reason for Recall / Hazard
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Product Description & Identification
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
Affected Products
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98642 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 6) CDS983782C, UDI-DI: 10193489592047(each), 40193489592048(case), Lot Number: 21DKA756; 7) DYKE1456D, UDI-DI: 10195327639938(each), 40195327639939(case), Lot Number: 24CBK289; 8) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 12) DYKE1955, UDI-DI: 101953... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 11575 units |
| Reason for recall | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260507 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.