MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit...
Reason for Recall / Hazard
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Product Description & Identification
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.
Affected Products
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98994 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 24BBF438; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23LBR516; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23LBI385; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBW083; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBT137; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBA705; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23EBT206; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBN853; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBG437; M... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 2340 units |
| Reason for recall | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260504 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260617 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.