The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →