Recall Z-2127-2017
Teleflex Medical · initiated April 21, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Codes / lots: Product Code: PE100, Lot numbers: 02F0801115, 02F0901859, 02G0802748, 02G0900814, 02H0900192, 02K0900567, 02L0900163, 02M0901006, 74A1601695, 74G1500137, 74G1502714 & 74M1400489.
Reason for recall
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
FDA-determined cause: Labeling False and Misleading
Action taken
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.
Details
- Recall number
- Z-2127-2017
- Initiated
- April 21, 2017
- Terminated
- January 27, 2020
- Product code
- GCD – Connector, Catheter
- 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.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2128-2017 Class II | PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/AccessoryLabeling: The expiration date is not stated on the labeling, there is a potential for expired product to be… | 04/21/2017Terminated |
| Z-2129-2017 Class II | PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter…Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be… | 04/21/2017Terminated |
| Z-2130-2017 Class II | INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory | 04/21/2017Terminated |