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Recall Observatory FDA recall evidence

Device product

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

Z-2130-2017

April 21, 2017

Class II

Product summary

Firm
Teleflex Medical
Event
Event 77081
Status
Terminated
Classification
Class II
Quantity
19,043 units in total
Official record key
device-enforcement:Z-2130-2017

Official wording

Reason: Unavailable

Code information: 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.

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