Medline D and C and cardiovascular packs contain substandard catheters
Medline D and C Packs and a custom cardiovascular pack are being recalled because representative samples did not meet applicable catheter performance specifications. 168 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.
Plain-English summary
Medline Industries, LP is recalling medical procedure kits labeled as D and C Pack (SKU DYNJ53973C) and PK Cust CV A&B Cabrini CO (SKU DYNJ60583C). The action covers 168 units.
During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the 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. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
- Manufacturer
- Medline Industries, LP
- Affected units
- 168
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each)
- 40195327008865 (case)
- Lot Number 21KME435
- Lot Number 21JMC247
- Lot Number 21JMB678
- Lot Number 21IMH919
- Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each)
- 40195327605583 (case)
- Lot Number 24CBO389
- Lot Number 24ABR872.
Distribution
Part of a larger recall action
This product is one of 30 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 30 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
FDA (Devices) · 2026-09-02
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
Same hazard · out of specification
See all →- ModerateDabigatran Etexilate Capsules Recalled Over Impurity Test Failure
FDA (Drugs) · 2026-07-29
- ModerateAquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
FDA (Devices) · 2026-07-15
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighMedline pre-connected urethral catheterization trays fail performance specifications
FDA (Devices) · 2026-06-24
- HighMedline 15 Fr urethral catheterization trays fail performance specifications
FDA (Devices) · 2026-06-24