MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
USMEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
Recalling Firm: Medline Industries, LP
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 CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98994 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; M... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 168968 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 |
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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.
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🚨 SAFETY ALERT: Medline Industries, LP - MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products) Check if your household is affected: https://therecallfile.com/recalls/medline-medical-procedure-kits-labeled-as-ch-open-heart-adult-cardiac/FDA-Z-2487-2026
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