Z-1635-2018Class II
Maximum Barrier Tray
Vygon U.S.A. / initiated 2018-02-28 / Terminated / root cause: sterility
Vygon U.S.A. began a recall of Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system on . FDA classified it as Class II and gives the reason as "Potential friction holes may affect the sterility of the product". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-1635-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Vygon U.S.A.
- Product
- Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
- Product code
- OWL Peripheral Catheter Insertion Kit
- Reason for recall
- Potential friction holes may affect the sterility of the product.
- Root cause tag
- sterility
- FDA root cause
- Under Investigation by firm
- Action
- The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: [email protected] including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers. If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at [email protected].
- Quantity in commerce
- 16520 total products
- Distribution
- Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
- Product codes and lots
- Lot Number: 17I024D UDI: 08498840010068
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1633-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1634-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1635-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1636-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1637-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1638-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1639-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1640-2018 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.