Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: structural-failure
device-separation
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 →

Same manufacturer · Teleflex Medical

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · structural failure