The Recall Desk
ModerateFDA (Devices)·Z-2127-2017·Announced 2017-05-31

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

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

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) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Straight 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 is distributed worldwide, including nationwide in the United States and to foreign consignees in Australia, Canada, China, Columbia, India, San Salvador, Singapore, and South Korea. The recall covers specific product code PE100 and multiple lot numbers, including 02F0801115, 02F0901859, 02G0802748, 02G0900814, 02H0900192, 02K0900567, 02L0900163, 02M0901006, 74A1601695, 74G1500137, 74G1502714, and 74M1400489.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and product codes. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor in accordance with the recall instructions.

The recalled product

Product
PE CONNECTOR 3/8 STRAIGHT 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 (12)

  • Product Code: PE100
  • Lot numbers: 02F0801115
  • 02F0901859
  • 02G0802748
  • 02G0900814
  • 02H0900192
  • 02K0900567
  • 02L0900163
  • 02M0901006
  • 74A1601695
  • 74G1500137
  • 74G1502714 & 74M1400489.

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 →