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Recall Observatory FDA recall evidence

Device product

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

Z-2128-2017

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-2128-2017

Official wording

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

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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