Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2128-2017·Announced 2017-05-31

Teleflex Medical Recalls PE Connector 3/8 Y 20/BX Due to Missing Expiration Date

Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Y 20/BX because the expiration date is missing from the labeling, creating a risk of using expired product.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error (missing expiration date) with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Y 20/BX, a sterile, single-use catheter connector/accessory. The recall was initiated because the expiration date is not stated on the product labeling. This labeling defect creates a potential for expired product to be used.

The affected product was distributed nationwide in the United States and to foreign consignees in Australia, Canada, China, Columbia, India, San Salvador, Singapore, and South Korea. The recall involves specific product code PE101 and a list of 38 distinct lot numbers.

Healthcare providers and consumers should stop using the affected product and contact Teleflex Medical for further instructions or a replacement.

The recalled product

Product: PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Manufacturer: Teleflex Medical
Category: Medical Device — Catheter Connector
Hazard: mis-labeling
expired-product
Affected units: 19,043

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Product Code: PE101
Lot numbers: 02A1100078
02A1403418
02B0900484
02B1201332
02C1002327
02C1101252
02D0802669
02D0803967
02D1101333
02D1101975
02D1201492
02E0900909
02F0800279
02F1101765
02G0802046
02G0900106
02G0902858
02G1302277
02H0901652

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Teleflex Medical

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · mis labeling