Recall Z-2128-2017 ยท GCD Connector, Catheter
Teleflex Medical
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
| Date | Apr 21, 2017 |
| Status | Terminated |
| Reason | Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. |
| Root cause | Labeling False and Misleading |
| Action | Consignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the Attn: Customer Service or email to recalls@teleflex.com. A Recall Acknowledgment Form was enclosed to be completed and returned via fax even if they have no stock. |
| Quantity | 19,043 units in total |
| Distribution | Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.