INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
This recall has been terminated (originally issued April 21, 2017).
- Company
- Teleflex Medical
- Recall Initiated
- April 21, 2017
- Terminated
- January 27, 2020
- Recall Number
- Z-2130-2017
- Quantity
- 19,043 units in total
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Distribution
Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.
Lot / Code Info
Product Code: PE103, Lot numbers: 02B1300991, 02B1402029, 02C1301654, 02E1201155, 02H1302224, 02K1100520, 02K1103125, 02K1200732, 02K1202185, 02L0701465, 02L0701959, 02L1201668, 02L1203112, 02M1201149, 74A1601005 & 74F1400876.74H1601152, 74J1601641, 74K1501590 & 74L1500555.
Root 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.