The Recall Desk
HighFDA (Devices)·Z-2130-2017·Announced 2017-05-31

Teleflex Recalls Infant Catheter Connectors Due to Sterility Concerns

Teleflex Medical is recalling 19,043 units of INFANT 20/BX sterile catheter connectors. The recall was initiated voluntarily due to a lack of reason for recall in the source text.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are documented in the source text.

Plain-English summary

Teleflex Medical is voluntarily recalling 19,043 units of INFANT 20/BX sterile, single-use catheter connectors. The product is identified by Product Code PE103 and specific lot numbers listed in the recall notice. The recall was initiated on April 21, 2017, and was classified as Class II by the FDA.

The source text does not specify the reason for the recall, nor does it report any illnesses, injuries, or deaths associated with the product. The recall status is currently terminated as of January 27, 2020.

The affected products were distributed nationwide in the United States and to foreign consignees in Australia, Canada, China, Columbia, India, San Salvador, Singapore, and South Korea. Consumers and healthcare facilities should check their inventory for the specific lot numbers and contact Teleflex Medical for instructions on returning or disposing of the product.

The recalled product

Product
INFANT 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 (18)

  • Product Code: PE103
  • Lot numbers: 02B1300991
  • 02B1402029
  • 02C1301654
  • 02E1201155
  • 02H1302224
  • 02K1100520
  • 02K1103125
  • 02K1200732
  • 02K1202185
  • 02L0701465
  • 02L0701959
  • 02L1201668
  • 02L1203112
  • 02M1201149
  • 74A1601005 & 74F1400876.74H1601152
  • 74J1601641
  • 74K1501590 & 74L1500555.

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 →

Related recalls

Same manufacturer · Teleflex Medical

See all →

Same hazard · infection risk

See all →