The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2129-2017·Announced 2017-05-31

Teleflex Medical Recalls PE Connector 5 In 1 Due to Missing Expiration Date

Teleflex Medical is recalling 19,043 units of PE Connector 5 In 1 catheter accessories because the expiration date is missing from the labeling, creating a risk that expired product may be used.

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 specific hazard is a labeling error (missing expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Teleflex Medical is recalling 19,043 units of PE Connector 5 In 1 20/BX, sterile, single-use catheter connectors and accessories. The recall was initiated because the expiration date is not stated on the product labeling. This labeling deficiency 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 PE102 and a list of designated lot numbers.

Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the product if the expiration date is not clearly stated on the labeling. Users should contact Teleflex Medical for further instructions on how to return or dispose of the recalled units.

The recalled product

Product
PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Manufacturer
Teleflex Medical
Category
Medical Device — Catheter Connector
Hazard
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: PE102
  • Lot numbers: 02A1101041
  • 02B1102552
  • 02C1001258
  • 02C1003795
  • 02C1101253
  • 02C1104114
  • 02D0802670
  • 02D0803968
  • 02D1000682
  • 02D1002136
  • 02D1101334
  • 02E1001502
  • 02E1100384
  • 02F0800281
  • 02F1000667
  • 02F1002368
  • 02F1101766
  • 02F1102607
  • 02F1103754

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 →

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