Z-0938-2025Class II
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model...
Sklar Corporation / initiated 2024-12-03 / Open, Classified / root cause: packaging
Sklar Instruments began a recall of ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE... on . FDA classified it as Class II and gives the reason as "Reports of various packaging issues that may result in a breach of the sterile barrier". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0938-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Sklar Corporation
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices
- Product code
- GEA Cannula, Surgical, General & Plastic Surgery
- Reason for recall
- Reports of various packaging issues that may result in a breach of the sterile barrier.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to [email protected]. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.
- Quantity in commerce
- 150 units
- Distribution
- Domestic: Nationwide Distribution
- Product codes and lots
- 1) 96-4176, UDI/DI 50649111493674, Lot codes: FSS4, FSS5; 2) 96-4177, UDI/DI 50649111493681, Lot codes: FSS4, FSS5; 3) 96-5434, UDI/DI 50649111493612, Lot codes: FSS4, FSS5; 4) 96-5435, UDI/DI 50649111493629, Lot codes: FSS4, FSS5, FSS6; 5) 96-5436, UDI/DI 50649111493636, Lot codes: FSS4, FSS5; 6) 96-5437, UDI/DI 50649111493643, Lot codes: FSS4, FSS5; 7) 96-5438, UDI/DI 50649111493650, Lot codes: FSS4, FSS5; 8) 96-5439, UDI/DI 50649111493667, Lot codes: FSS4, FSS5; 9) 96-5440, UDI/DI 50649111493964, Lot codes: FSS4, FSS5; 10) 96-5492, UDI/DI 50649111481657, Lot codes: FSS4, FSS5; 11) 96-5493, UDI/DI 50649111481664, Lot codes: FSS4, FSS5; 12) 96-5494, UDI/DI 50649111481671, Lot codes: FSS4, FSS5.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0925-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0926-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0927-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0928-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0929-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0930-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0931-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0932-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0933-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0934-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0935-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0936-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0937-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0938-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0939-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0940-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0941-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0942-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0943-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0944-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0945-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0946-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0947-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0948-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0949-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0950-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0951-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0952-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0953-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0954-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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