Z-1015-2023Class II
Centurion Medical Products, Silver Antimicrobial Vad Drive, Ref Dt18760
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-12-23 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 on . FDA classified it as Class II and gives the reason as "The kit contained an expired component". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1015-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion Medical Products, Silver Antimicrobial Vad Drive, Ref Dt18760
- Product code
- OXQ Dressing Change Tray
- Reason for recall
- The kit contained an expired component.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."
- Quantity in commerce
- 1050 kits
- Distribution
- US Nationwide distribution in the states of NY, IN, FL, NJ, IL.
- Product codes and lots
- UDI/DI 10653160274841, Lot Numbers 22ABO498
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1015-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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