The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1399-2017·Announced 2017-03-15

Parker Medical Recalls Left Double Lumen Endobronchial Tubes

Parker Medical is recalling specific lots of Left Double Lumen Endobronchial Tubes because the single lung isolation feature did not function as intended.

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 3/5 (High).

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, and the hazard involves a medical device failing to provide intended single lung isolation during surgery, which presents a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Parker Medical is recalling 1,060 units of Parker Left Double Lumen Endobronchial Tubes with Parker Flex-Tip. The affected model numbers are H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, and H-PFTDL-41-1. The specific lot numbers involved are 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, and 1605DL0814F.

The recall was initiated because the product was not functioning as intended. While ventilation to the patient was not disrupted, the single lung isolation and ventilation capabilities did not perform as designed. These devices are used for intubating patients and providing oxygen and anesthetic agents during surgical procedures.

The affected units were distributed nationwide to Colorado, Florida, Indiana, South Carolina, and Texas, as well as to one Virginia consignee. Healthcare facilities should check their inventory for these specific model and lot numbers and stop using the affected devices.

The recalled product

Product
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung…
Manufacturer
Parker Medical
Category
Medical Device — Endobronchial Tubes
Hazard
Affected units
1,060

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 (9)

  • Lot Numbers: 1605DL0814A
  • 1605DL0814B
  • 1601LD2001C
  • 1605DL0814C
  • 1601DL2001D
  • 1605DL0814D
  • 1601DL2001E
  • 1605DL0814E
  • 1605DL0814F

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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