Teleflex Recalls Tracheopart Sets Due to Connector Detachment
Teleflex is recalling sterile Tracheopart Sets because the cobb connector may detach from the main connector before use.
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 mechanical failure of a medical device component prior to use, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Teleflex, Inc. is recalling sterile Tracheopart Sets (Left) due to customer complaints that the cobb connector detached from the main connector prior to use. The affected products include specific batch numbers for product codes 116400-000750, 116400-000850, and 116400-000950.
The recall covers distribution in numerous US states, DC, Puerto Rico, and several international locations including Canada, Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago. The agency has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected Tracheopart Sets and contact Teleflex for further instructions or a replacement.
The recalled product
- Product
- Tracheopart Set (Left), Sterile
- Manufacturer
- Teleflex, Inc.
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)
- Produce Code 116400-000750 Batch Number 13FT06
- 13GE28J
- 13GE31J
- 13GT11
- 13GT29
- 13IT05
- 13IT16
- 13JT11
- 13JT21R
- 13JT25R
- 13KT05R
- 13LT11
- 14BT09
- 14BT15
- 14CT16
- 14CT20
- 14DE16J
- 14DT19
- 14FE24J
- 14FT16
Distribution
Part of a larger recall action
This product is one of 9 recalled by Teleflex, Inc. 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 9 products in this recall →Related recalls
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