MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/S...
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) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.
Affected Products
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98994 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23JBM539; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23IBF088; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23FBM203; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBK233; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBB115; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22IBO304; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22HBR331; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22FBM460; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22DBS093; M... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 4801 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.