FDAClass IIMay 31, 2017

PE Connector 3/8 Y 20/bx recall: Labeling Error

PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

Why was PE Connector 3/8 Y 20/bx recalled?

Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: PE101, Lot numbers: 02A1100078, 02A1403418, 02B0900484, 02B1201332, 02C1002327, 02C1101252, 02D0802669, 02D0803967, 02D1101333, 02D1101975, 02D1201492, 02E0900909, 02F0800279, 02F1101765, 02G0802046, 02G0900106, 02G0902858, 02G1302277, 02H0901652, 02H0902603, 02H1103939, 02K0900568, 02K1000269, 02K1001997, 02K1103123, 02K1301033, 02L0701464, 02L0901521, 02L1002578, 02L1003527, 74A1601696, 74C1601057, 74E1600942, 74E1602825, 74F1401270, 74H1501378, 74J1502624 & 74L1500554.

Product
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Recalling firm
Teleflex Medical
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.
Recall date
May 31, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls