Stryker Heated Tube Set Recall for Leaking and Detachment Issues
Stryker is recalling 19,083 boxes of Heated Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
What this means for you
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 defect involves a functional failure (leaking/detaching) of a medical device used in procedures, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Stryker Corporation is recalling 19,083 boxes of Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690. This product is a disposable, sterile accessory used with the PNEUMO SURE High Flow Insufflator. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated because the heated tube sets were consistently leaking and detaching from the cassette. This defect could potentially compromise the function of the insufflator system during medical procedures.
The affected products were distributed nationwide to medical facilities, including government and military distribution. Foreign distribution included Argentina, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Saudi Arabia, UAE, and Uruguay. The source text does not specify specific dates of distribution or the number of patients affected. Medical facilities should stop using the affected lots and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 19,083
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)
- UDI - 07613327055658
- Lot numbers: 56004333
- 56004335
- 56004337
- 56004342
- 56004352
- 56004375
- 56004393
- 56004419
- 56004421
- 56004423
- 56004435
- 56004445
- 56004447
- 56004465
- 56004481
- 56004485
- 56004512
- 56004520
- 56004534
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Corporation 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 3 products in this recall →Related recalls
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