Recalls / —

—#154939

Product

INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory

FDA product code

GCD — Connector, Catheter

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected 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.

Why it was recalled

—

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm

Teleflex Medical

Address

2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern

Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.

Timeline

Recall initiated

2017-04-21

Terminated

2020-01-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #154939. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.