The Recall Desk
SevereFDA (Devices)·Z-2369-2015·Announced 2015-08-26

Teleflex Sheridan SHER-I Bronch Accessory Pack Recalled for Connector Defect

Teleflex Medical is recalling Sheridan SHER-I Bronch Accessory Packs because the double swivel connector may crack or separate on the endobronchial tube.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric, as the defect presents a reasonable probability of serious adverse health consequences.

Plain-English summary

Teleflex Medical is recalling the HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, a sterile, prescription-only medical device used to aspirate liquids or semisolids from a patient's upper airway. The recall involves 188,195 total units distributed nationwide in the United States and in the Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand, and Vietnam.

The recall was initiated because the double swivel connector on the device may crack or separate on the endobronchial tube. The affected product code is 5-16142, and the specific lot numbers involved are 01J1300535, 01M1300215, 01A1400321, 73D1400579, and 73E1400113.

Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected units. Patients who have received this device should contact their healthcare provider for guidance on next steps.

The recalled product

Product
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
Manufacturer
Teleflex Medical
Category
Medical Device — Respiratory / Airway Management
Hazard
Affected units
188,195

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 (5)

  • Product Code: 5-16142
  • Lot numbers: 01J1300535
  • 01M1300215
  • 01A1400321
  • 73D1400579 and 73E1400113.

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 · structural failure

See all →