Teleflex Medical Recalls Sheridan Double Swivel Connectors Due to Cracking Risk
Teleflex Medical is recalling Sheridan double swivel connectors because they may crack or separate on endobronchial tubes.
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 recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The double swivel connector may crack or separate on the endobronchial tube."
Plain-English summary
Teleflex Medical is recalling 188,195 units of HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel connectors. These sterile, prescription-only medical devices are used temporarily to make a flexible tracheal tube rigid to aid its insertion into a patient.
The recall was initiated because the double swivel connector may crack or separate on the endobronchial tube. The affected products were distributed worldwide, including in the United States and in The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand, and Vietnam.
Healthcare providers should stop using the affected lots and contact Teleflex Medical for instructions on how to return the devices. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Respiratory
- 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 (19)
- Product Code: 5-15401
- Lot numbers: 01K1300254
- 01L1300393
- 01M1300212
- 01A1400436
- 01C1400086
- 73D1400096
- 73D1400496
- 73E1400269
- 73F1400153
- 73F1400352
- 73G1400052
- 73G1400288
- 73H1400331
- 73J1400401
- 73L1400106
- 73M1400208
- 73A1500345
- 73B1500272 and 73C1500255.
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.
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Similar recalls
- SevereTeleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes Due to Disconnection Risk
FDA (Devices) · 2019-06-26
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