CLASS II Device recall · Reported 31 May 2017 · FDA Enforcement Report

PE Connector 3/8 Y 20/BX, Sterile, Single use recalled

Teleflex Medical is recalling PE Connector 3/8 Y 20/BX, Sterile, Single use, distributed nationwide in the US. The recall was initiated on 21 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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.

Quantity recalled19,043 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2128-2017
FDA event ID: 77081
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Terminated
Recall initiated: 21 Apr 2017
FDA classified: 22 May 2017
Reported: 31 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Apr 2017	Recall initiated by company
22 May 2017	Classified by FDA	+31 days
31 May 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots 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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 77081

Reported	Class	Recall	Company	Reason	Where
31 May 2017	CLASS II	PE Connector 3/8 Straight 20/BX, Sterile, Single use recalled	Teleflex Medical	Other	Nationwide
31 May 2017	CLASS II	PE Connector 1 20/BX, Sterile, Single use recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
31 May 2017	CLASS II	Infant 20/BX, Sterile, Single use recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide

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